MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH METASUL CLS SPOTORNO, INSERT, 58/28; N/A

Model Number N/A

Device Problems Material Erosion (1214); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problems Foreign Body Reaction (1868); Local Reaction (2035); Joint Dislocation (2374); Metal Related Pathology (4530)

Event Date 07/22/2021

Event Type  Injury  

Manufacturer Narrative

Medical products: cls cup hip impl win gen; catalog #: unknown; lot #: unknown, cocr head hip impl win gen; catalog #: unknown; lot #: unknown.Therapy date: unknown.The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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

It was reported that the patient was implanted with liner on an unknown side and underwent a revision surgery due to metallosis.

Event Description

It was reported that the patient was implanted with liner on an unknown side and underwent a revision surgery due to metallosis and instability of the joint.Patient has experienced recurrent dislocations also.

Manufacturer Narrative

D10: medical products: cls cup hip impl win gen; catalog#: unknown; lot#: unknown.Cocr head hip impl win gen; catalog#: unknown; lot#: unknown.Therapy date: (b)(6) 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that the components were revised due to metallosis.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.Zimmer biomet product experience report (zper).The event information section of the zper mentions that the components were explanted due to metallosis.Email from the surgeon.The email informs about the implantation and revision date, as indicated on the first page of this report.It is also stated that the small metal on metal pairing had recurrent dislocations after 22 years.Swissmedic report: no additional information.X-ray evaluation: one undated pelvis overview was received.It shows identical total hip prostheses implanted in the left and right hip, including a cls stem and cls cup with metasul pairing.For both prostheses, the cup has a rather high anteversion angle.The posterior edge of both shells is not covered by bone.Product evaluation: visual examination: revision damage in the form of scratches, nicks and deformed segments can be observed on the cls shell.On almost the entire anchoring surface of the shell bone attachments are noticeable.Bone attachments can be seen as well on the inner side of the shell.On the inner side of the shell numerous small line-shaped, shiny polished areas can be seen on the thread.On the anchoring side of the cls metasul insert the polyethylene liner is slightly yellow discolored.Abraded areas can be recognized in the polar region.The structure of the thread is no longer in its original condition.On the thread there are small shiny polished areas, sheared off areas, abraded areas as well as embedded metallic particles visible.On the articulation side of the insert, the polyethylene rim shows damage in the form of coarse scratches and a screw hole, most probably from revision surgery.Around the location of the screw hole there is a layer delamination which is bulged and centrally pressed in.Adjacent to this, on the rim of the metasul inlay smearing can be recognized over the entire width of the rim a length of approximately 13 mm.Close to this area, the bevel of the spherical calotte is worn.Within the area of the worn bevel, a small nick can be seen on top of the rim.Close to the nick, the top of the rim is smeared on a length of approximately 5 mm.Below the nick, organic deposits can be seen along the bevel of the spherical calotte until the location of the screw hole.Whitish areas with subsurface cracks and some cracks over the entire width of the polyethylene rim can also be observed on the articulation side of the insert.On the articulation surface of the metasul inlay a partial borderline between the loaded and unloaded area can be noticed with the unaided eye.Matt greyish areas are visible as well.The investigation of the metasul inlay with a low power microscope revealed that the greyish areas consist of micropits.An area with arrow shaped formations was observed just below the worn bevel, on the spherical calotte.On the articulation surface of the metasul head a complete borderline between the loaded and unloaded area is visible.All around the borderline, organic deposits can be recognized along the unloaded side of the borderline.Around the head¿s pole, a matt greyish zone can be noticed in the loaded area.Two crossed stripes are recognizable in the pole region.The articulation surface of the head was investigated under the light microscope at 200-times magnification with differential interference contrast (dic).As already visible with the unaided eye, the borderline between the loaded and the unloaded area that is covered partially by organic deposits is well recognizable.A large zone of the loaded area is matt greyish and consist of micropits.Indentations and areas with parallel scratches could be observed in the loaded area.In the loaded area, fine scratches can be recognized and the carbides, which protruded slightly in the original surface state, are leveled.The original surface state with slightly protruding carbides is still visible in the unloaded area.The head taper show surface changes due to corrosion and fretting corrosion of different width on the distal end of the contact area with the stem taper.Wear measurement: the wear measurements of the articulation surfaces of the metasul head and cls metasul insert were carried out on a 3d measuring machine type cmm5, sip geneva.The total, linear wear value for the head is 89.4 ¿m which results in an annual wear rate of 4.1 ¿m.In alignment with the visual examination the cmm measurement detected a wear zone close to the bevel for the cls metasul inlay.The total, linear wear value amounts to 53 ¿m resulting in an annual wear rate of 2.4 ¿m.Due to the measuring method it is not possible to measure the entire articulation surface of the inlay.The measurement only covers the surface from the center of the component up to 80°.Due to the position of the loaded zone it has to be assumed that the wear area could not be measured entirely.Therefore, the wear value indicated above does not reflect the true amount of wear.For a metasul pairing with diameter 28 or 32 mm retrieved within the first year an average wear of 27.8 ¿m / year per pairing was found.Retrievals explanted after two and more years in-vivo had an average wear rate of 6.2 ¿m / year per pairing.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.Conclusion: according to the received information the hip prosthesis was implanted in (b)(6) 1999 and revised due to metallosis (according to zper) in (b)(6) 2021 after 21 years and 8 months in vivo.In addition, the surgeon mentioned that the small metal on metal pairing had recurrent dislocations after 22 years.On the undated x-ray at hand, there are identical total hip prostheses implanted in the left and right hip.Both cups are implanted with a rather high anteversion angle.As the complete x-ray follow-up is not at hand, it stays unknown if this was the situation immediately after implantation or if it changed over time in vivo.It is also unknown which side was revised.The appearance of the shell indicates that it was well osseous integrated.Bone on growth could also be observed on the inner side of the shell leading to abraded areas in the pole region of the cls metasul insert.The numerous small line-shaped, shiny polished areas seen on the thread of the insert and shell could point to some micromotion between the parts.On the articulation side of the insert, the area on the polyethylene rim with layer delamination which is bulged and centrally pressed in as well as the approximately 13 mm smearing on top of the metasul inlay, indicate an impingement with the stem¿s neck.The appearance of the articulation surfaces of the metasul inlay (worn bevel and smearing on the rim) and metasul head (indentation and areas with parallel scratches) points to a subluxation situation leading to rim loading.Compared to the annual wear rate measured on the metasul pairing can be considered slightly elevated.However, due to the position of the wear zone of the inlay the wear area close to the bevel could not be measured completely.Based on the retrieval investigation it came to a rim loading situation triggering recurrent dislocations most probably due to the rather high anteversion angle of the cup after approximately 22 years in vivo.This and the impingement with the neck¿s stem could have resulted in metallosis reported by the surgeon.It is unknown if the surface changes seen on the taper of the head could have contributed in any way to this as well.The layer delamination and the cracks on the polyethylene rim can be attributed to material oxidation.The sheared off areas on the insert¿s thread could have possibly derived from the attempt to remove the part with a screw and not by unlocking the thread.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.However, the most likely root cause for the reported error pattern is the rather high anteversion angle of the cup after approximately 22 years in vivo.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2021-00472-2.

Event Description

Investigation has been completed.

• Brand Name: METASUL CLS SPOTORNO, INSERT, 58/28
• Type of Device: N/A
• 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: 12432785
• MDR Text Key: 271658317
• Report Number: 0009613350-2021-00473
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/15/2002
• Device Model Number: N/A
• Device Catalogue Number: 60.13.28-58
• Device Lot Number: A835230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/1998
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male