MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL, ALPHA INSERT, II/32; HIP PROSTHESIS

Model Number N/A

Device Problems Material Erosion (1214); Material Integrity Problem (2978)

Patient Problems Arthralgia (2355); Metal Related Pathology (4530); Implant Pain (4561)

Event Date 09/09/2021

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.Medical products: metasul, head, m, 32/0, taper 12/14; catalog#: 19.32.06; lot#: 2507046e09.Allofit-s alloclassic, shell with polar screw plug, uncemented, 52/ii; catalog#: 4265; lot#: 2504066d09.Avenir mller, stem, standard, uncemented, ha, 4, taper 12/14; catalog#:01.06010.004; lot#:4013608e09.Therapy date: (b)(6) 2021.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on an unknown side and experienced pain and blockages.The surgeon performed a revision surgery and found metallosis and granulomas associated with early wear of the prosthesis.Chroma and cobalt levels were elevated.The acetabulum and femoral head were changed and an allograft was performed.

Event Description

It was also reported that in view of the abnormal biology they resumed the surgery.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of initial medwatch.New information received: patient weight patient date of birth contributing conditions investigation of this incident is currently ongoing, a follow up report will be submitted when additional information becomes available.The following reports are associated with this event: 0009613350-2021-00483.Zimmer biomet¿s reference number of this file is (b)(4).

Manufacturer Narrative

Product has been received by zimmer biomet.Investigation results are now available.Investigation and conclusion 1.Event description: it was reported that the prosthesis was implanted in 2009.The patient went for a consultation due to pain and blockages.Dr.Tesson performed a revision surgery in (b)(6) 2021 and found metallosis and granulomas associated with early wear of the prosthesis.Harm: s3 - pain or ache, moderate hazardous situation: implant deteriorates, breaks or loses function postoperatively.2.Review of received data: - due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.2.1 information entered in quality system database (etq) on (b)(6) 2021 the below information was received: implanted in 2009 - she consulted for pain and blockages.Dr.Tesson performed a revision surgery on (b)(6) 2021 and found metallosis and granulomas associated with early wear of the prosthesis.Chroma and cobalt levels were elevated.The acetabulum and femoral head were changed and an allograft was performed.On (b)(6) 2021 additional information was received in an email answering specific questions.The information not mentioned on the first page of this report is displayed below: operated in 2009, implantation report is not available left hip op: (b)(6) 2009 right hip op: (b)(6) 2009.Revision report not available x-rays not available were there any contributing conditions related to the event? severe effects of epiphysiolysis of the hip, since 1 year, painful deterioration of her right hip with sensation of tightness.In view of the abnormal biology, the decision was made to resume surgery.3.Product evaluation: 3.1 as-received condition of the explants and check of manufacturing documents: the explants of the case at hand were received each separately packed.The manufacturing documents of the parts were inspected.According to the lot no the received avenir müller stem was produced in (b)(6) 2018, whereas the allofit-s alloclassic shell, the metasul alpha insert and the metasul head were manufactured between (b)(6) and (b)(6) 2009.Considering the given implantation date the avenir müller stem cannot belong to the current case and is therefore not investigated.3.2 visual examination: on the anchoring side of the allofit-s alloclassic shell bone attachments are visible mainly in the half of the screw holes.In the latter the shell is heavily damaged most probably due to the revision surgery.The polar screw plug exhibits bone ongrowth on the anchoring side and damage deriving from implantation and / or revision on the inside.On the inside of the shell and its rim damage, e.G.Scratches, instruments marks and spots deriving from the use of an electrosurgical tool, can be noticed as well primarily in the half of the screw holes and the polar region including the thread for the plug.Bone attachments are present in the countersunk zone of two screw holes and in one location along the distal edge.Fine polished lines and spots can be recognized mainly in the half of the screw holes including the vertical area of the snap feature and the polar region.The anchoring side of the metasul alpha insert shows two grooves each starting from the indentation of the shell¿s antirotational spikes.The grooves consist of lined up single indentations sometimes with a small space in between.The pole pin is slightly deformed.Imprints from the shell¿s screw holes are clearly visible.Closer inspection using a low power microscope (type leica mz16 a eq-id wnt-03-rsr-540-151663), revealed that some exhibit a double contour or have several indentations from the screw hole¿s edge.Further, on three of the indentations the machining marks are almost completely obliterated.Signs of backside wear can be recognized on the surface around the indentations.On the opposing side slight imprints from the shell¿s screw holes can be detected under certain lighting conditions.The machining marks on this side of the insert are largely obliterated as well.The original surface structure with the machining marks is only still evident in a small area close to the rim.On the proximal part of the rim the machining marks are obliterated on the entire circumference.Additionally, some damage including a chisel cut-in most probably deriving from the removal of the insert from the shell can be seen on the anchoring side and the polyethylene rim on the articulation side.There, about half of the rim¿s circumference is partially slightly yellowish discolored and shows subsurface cracks.In the discolored area the polyethylene appears slightly bulged.A part of the polyethylene is lifted most probably due to an instrument damage.On the rim of the latter various smearing as well as spots deriving from the use of an electrosurgical tool can be noticed.A slightly off-center circular area with probably organic deposits and an arrow-shaped smearing is visible on the inlay¿s articulation surface.The spherical calotte was further examined using a low power microscope (type leica mz16 a eq-id wnt-03-rsr-540-151663).Close to the bevel a mixture of scratches and arrow-shaped formation could be found.On the articulation surface of the metasul head coarse scratches and smearing as well as spots originating from the use of an electrosurgical tool are present.In addition, a borderline between the loaded and unloaded area, a slightly grayish zone and a small grayish stripe are visible.The latter extents across the loaded area.The articulation surface was inspected under the microscope (nikon epiphot, eq-id wnt-03-rsr-540-151662) at 200-times magnification with differential interference contrast (dic).The borderline between the loaded and the unloaded area and the several types of damage are well recognizable.In the slightly grayish zone and the small grayish stripe micropits are visible.Also in other areas micropits can be seen.In parts of the loaded area without the before mentioned phenomena fine scratches can be recognized and the carbides, which protruded slightly in the original surface state, are leveled.It seems that zones showing the original surface state with the slightly protruding carbides do no longer exist on the entire surface.Instead the surface is damaged and scratched.On the head taper a groove of about 0.5 mm in width due to corrosion can be seen.Adjacent to the groove surface changes due to fretting and fretting corrosion are present on the entire contact area with the stem taper.At the proximal end of the latter two marks can be detected which appear to be slightly higher than the surrounding surface.3.3 wear measurement: the wear measurement was carried out on a 3d measuring machine type cmm5, sip geneva.The total linear wear value is 131.6 microm for the head which results in a wear rate of 11.2 microm / year.The wear map of the insert did not show a clear wear zone.But, the method to determine the wear requires an unworn area on the same parallel of measurement points.Therefore, it is not possible to determine a wear value.However, the measured diameter of the insert is no longer within the manufacturing tolerances which could indicate the presence of some wear.For a metasul-pairing with diameter 28 or 32 mm retrieved within the first year an average wear of 27.8 microm / year per pairing was found (1).Retrievals explanted after two and more years in-vivo had an average wear rate of 6.2 microm / year per pairing (1).4.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.5.Conclusion: after approximately 11 years and 9 months the allofit-s alloclassic shell combined with a metasul pairing was revised.There is only little information at hand.It seems that the patient consulted the surgeon because of pain and blockage.Additionally, there was a painful deterioration of the right hip with sensation of tightness since one year mentioned.During revision surgery metalosis and granulomas associated with early wear of the prosthesis were found.The acetubular component and the femoral head were revised and allografting was performed.Elevated chromium and cobalt levels were also reported.However, the actual test results were not provided.Further, it is stated that a total hip arthroplasty was performed on the left hip in 2009 as well.From the little clinical information provided it is concluded that the retrievals at hand had been implanted in the patient¿s right hip.The appearance of the retrieved acetabular component at hand: fine polished lines and spots on the inside of the shell on the anchoring side of the insert: grooves, backside wear, obliterated machining marks imprints from the shell¿s screw holes showing double contour or several indentations from the screw hole¿s edge and obliterated machining marks slight imprints from the shell¿s screw holes on opposite half points to a relative movement between the insert and the shell.This probably resulted in some polyethylene wear.The subsurface cracks seen on the rim of the metasul alpha insert can be attributed to oxidation of the material most probably during time in vivo.Due to the little information received the phenomena seen on the articulation surfaces of the metasul pairing cannot be assigned to specific events, e.G.Subluxation / dislocation.Only taking into account the wear value measured for the head, the wear can be considered as elevated compared to (1).On the head taper surface changes due to corrosion, fretting and fretting corrosion as well as marks were found.The reasons for these remains unknown.There are several factors that influence the quality of the taper connection, e.G.Impaction force and angle as well as the condition of the taper surface during mounting (wet, dry).Concerning the marks, due to the current literature a similar phenomenon was observed for a bi-modular hip design of a different alloy composition (2, 3).The phenomena detected on the head taper as well as the articulation wear could have contributed to the reported issues (pain, elevated cobalt and chromium values, deterioration of the hip, metalosis and granuloma).Further the possible polyethylene wear deriving from the relative movement of the insert in the shell could also have contributed to granuloma and deterioration of the hip.Based on the received information and the retrieval investigation the reason for the blockage and the sensation of tightness experienced by the patient remains unknown.It also stays unknown, why it came to a relative movement of the insert in the shell.Based on the investigation the reported event can be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.6.References: (1) rieker cb, schoen r, koettig p, shen m, krevolin j, 2006, in-vitro versus in-vivo analysis of metal-on-metal articulations, abstract 7892 of the 5th world congress of biomechanics, jul 29-aug 4, munich, germany, journal of biomechanics 2006; vol.39 suppl.1, p.120.(2) di laura a, hothi hs, henckel j, kwon ym, skinner ja, hart aj, retrieval findings of recalled dual-taper hips, j bone joint surg am.2018;100:1661-72.(3) bryant m, buente d, oladokun a, ward m, huber g, morlock m, neville a, surface and subsurface changes as a result of tribocorrosion at the stem-neck interface of bi-modular prosthesis, biotribology 2017 jun;10:1-16.Ziommer's reference (b)(4).If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

Investigation results are now available.Attempts have been made and no further information has been provided.

• Brand Name: METASUL, ALPHA INSERT, II/32
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12511558
• MDR Text Key: 272644895
• Report Number: 0009613350-2021-00482
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: N/A
• Device Catalogue Number: 01.00010.709
• Device Lot Number: 2500441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: 09/08/2021; 03/30/2022
• Supplement Dates FDA Received: 11/03/2021; 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 170 KG