MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 55, TAPER 12/14; HIP PROSTHESIS

Model Number N/A

Device Problems Mechanical Problem (1384); Migration (4003)

Patient Problems Pain (1994); Arthralgia (2355)

Event Date 03/18/2021

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states.The manufacturer received x-rays and 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 with a revitan stem on an unknown side and underwent a revision surgery due to pain and rotation of the proximal part of the stem.

Manufacturer Narrative

D10 concomitant medical products: biolox delta head hip impl win gen , item# unknown, lot# unknown.Event description: it was reported that patient underwent a revision surgery due rotation of the proximal part of the revitan.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.Intraoperative photos and x-ray: the intraoperative photos show a part of the explanted biolox head and revitan stem in anterior and posterior view.All parts (biolox head, proximal and distal part) are still mounted to each other.The proximal part and the proximal area of the distal part of the stem are depicted.It seems that the space between the two parts is rather small or not existing at all.The x-ray provided seems to be a photo of the x-ray displayed on a screen and has a limited quality.The x-ray shows the ap view of a right hip where a total endoprosthesis including a revitan stem is implanted.Additionally, four cerclage wires are visible.On the x-ray the sizes of the components are indicated.However, there is no date.On the lateral side and shoulder of the proximal part of the stem a radiolucent line bordered by a sclerotic line on the bone side can be seen.Approximately half of the length of the stem¿s neck is surrounded by bone.On the medial side a radiolucent gap is recognizable that extends till the middle cerclage wire.There seems to be a healed bone fracture on the medial side above the most distal cerclage.Product evaluation: as-received condition and disassembly: the parts were received in a pouch for steam sterilization and still mounted as described above for the intraoperative photos.The proximal part of the revitan stem was firmly fixed to the distal part and could not be rotated by hand.The stem to head position was marked and the head removed for better handling.Afterwards all parts were cleaned and disinfected.According to the markings on the parts of the stem, the proximal part was in an almost 40° position to posterior so that there was only little space between the shoulders of the two parts medial posteriorly and lateral anteriorly respectively.There seemed to be no space between the face surface of the proximal stem part and the face of the shoulders of the distal stem part, i.E.No space between the two parts in ap direction.Further, the lateral edge of the posterior shoulder of the distal stem part was slightly protruding the face surface of the proximal stem part.On the other side there was space between the face of the shoulders of the proximal stem part and the face surface of the distal stem part and, i.E.Space between the two parts in ml direction.Using a feeler gauge, the distance between the two parts was measured.The latter amounted to 0.1 mm on the medial side and 0.3 mm on the lateral side.The conical nut was mounted on the thread of the connection pin in such a position that the face surface of the nut was higher than that of the connection pin.The nut was loose and could be removed by hand.Underneath the nut the space surrounding the pin¿s thread was filled with a blackish appearing deposit which was removed.There were also deposits on the backside of the nut before disassembly of the proximal part, the position of the proximal stem part to the distal stem part as well as the position of the connection pin in the stem body were marked.The distal part of the stem was clamped in a vice.The revitan handle for counterforce (01.00409.809) was used to remove the proximal part by applying a combination of rotational and tensional movements/forces.A movement of the connection pin could not be observed.After removal various deposits were present on the connection pin as well as the inner side of the proximal stem part.The height of the connection pin was measured using a caliper and found to be according to drawing.The parts were cleaned to remove the deposits and disinfected again.Visual examination: the stem¿s neck shows several blackish spots and lines most probably deriving from the use of an electrosurgical tool.On the anchoring surfaces of the revitan stem revision damage in the form of scratches and instrument marks is visible.Sparse remains of bone attachments can be seen in the distal half of the distal stem part.Under certain lighting conditions tiny, polished spots and lines are recognizable in the proximal region on the lateral side of stem, especially in the area without fins of the distal stem part.The conical nut is inconspicuous.The inner side of the proximal part and the connection pin of the distal part of the revitan stem were examined with a low power microscope.On the anterior as well as posterior face surface of the proximal part a polished zone is visible due to contact with the faces of the shoulders of the distal stem part showing as well polished zones.The inner side of the part exhibits surface changes including marks appearing protruding/missing from the surrounding surface in the distal taper region.In the proximal area of the cylindrical region there seems to be a zone of surface changes on the lateral side.Further deposits are recognizable.Such can also be seen in the distal area of the proximal tapered region.Otherwise these two regions appear inconspicuous.The connection pin shows surface changes.In the cylindrical region corrosion, polishing and possibly some fretting and in the distal taper region a mixture of corrosion, fretting, fretting corrosion, oxide layer and smeared material is detectable.In the latter also marks appearing protruding/missing from the surrounding surface probably matching with those on the inner side of the proximal part can be seen.In the distal taper region, the surface changes partially extent to the adjacent area.The edge between the distal taper region and the cylindrical region of the connection pin is no longer palpable on the medial side.Closer inspection of the distal taper region of the pin using a light microscope revealed cracks on the medial side in addition to the above mentioned phenomena.The biolox delta head exhibits diffuse metallic smearing on the articulation surface, the bevel and the bottom.On the head taper material transfer from the stem taper due to proper fixation and removal can be seen.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: after 10 years in vivo the revitan stem combined with a biolox delta head was revised.According to the zper the patient had pain and in the event description rotation of the proximal part is mentioned.It remains unknown how and at what point in time the latter was detected.The situation displayed on the x-ray received could point to loosening and possibly little subsidence of the stem.Both could be possible sources for the patient¿s pain.However, the date on which the x-ray was taken is unknown.A complete x-ray follow-up would be necessary to show if these two phenomena could have developed over time in vivo.In the as-received condition the conical nut was loose and could be removed by hand.Both parts of the stem were firmly fixed to each other and could not be rotated by hand.To disassemble the parts a combination of rotational and tensional movements/forces was necessary using the handle for counterforce.According to the markings on the parts of the stem the proximal part was in an almost 40° position to posterior.It stays unknown, if this was the original position at the time of implantation surgery or if it changed over time in vivo.Further, it was observed that there was no distance between the proximal and the distal stem part on the anterior and posterior side while on the medial side a distance of 0.1 and on the lateral side a distance of 0.3 mm could be measured.According to the surgical technique in chapter implants ¿ concept ¿ instrumentation, the implants, characteristical description on page 5 valid at the time of implantation, it is stated that after the assembly: a gap of about 1 mm between the 2 components enables micromovements without inducing the formation of any metal debris.Therefore, the distance between both parts determined on the retrievals at hand is too small compared to the above.The loose conical nut, the gap between the two parts, that does at least not exist on two sides, as well as the fact that the disassembly of the parts was successful only by applying a combination of rotational and tensional movements/forces could point to a loosening and subsidence of the proximal part on the connection pin.As there is almost no clinical information at hand the further background of the case as well as a possible sequence of events and their reasons remain unknown.After disassembly and cleaning of the parts, surface changes were found on the inner side of the proximal part as well as on the connection pin of the distal part of the revitan stem.It remains unknown if these changes could have contributed to the patient¿s pain and the mentioned rotation of the proximal part.Based on the investigation the reported event cannot 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.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).

Event Description

No change to previously reported event.

• Brand Name: REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 55, TAPER 12/14
• 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: 11705523
• MDR Text Key: 247301152
• Report Number: 0009613350-2021-00181
• Device Sequence Number: 1
• Product Code: JDI
• 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
• Report Date: 02/01/2022

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: Lay User/Patient
• Device Expiration Date: 04/30/2015
• Device Model Number: N/A
• Device Catalogue Number: 01.00402.055
• Device Lot Number: 2558472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 04/22/2021
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2010
• 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