MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZIMMER MMC, CUP, UNCEMENTED, 54 MM/46 MM, CODE L; ZIMMER MMC CUP

Model Number N/A

Device Problems Degraded (1153); Fracture (1260); Biocompatibility (2886); Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Cyst(s) (1800); Bone Fracture(s) (1870); Muscle Weakness (1967); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 04/18/2018

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 ldh, head, 46, code l, taper 18/20; catalog#: 01.00181.460; lot#: 2431254.Metasul ldh, head adapter, m, 0, taper 12/14-18/20; catalog#: 01.00185.146; lot#: 2516387.Femoral stem press-fit collarless 12/14 neck taper standard body standard neck offset size 13 138mm stem length cementless; catalog#: 00-7864-013-00; lot#: 61256425.Therapy date: (b)(6) 2018.The manufacturer received 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 the right side and underwent a revision surgery due to alval, pelvic ring fracture, muscle weakness and muscle destruction due to alval, elevated metal ion levels, pseudocyst with fluid collection, trunnionosis with a blackened trunnion and fibrous component on the acetabular component.There was approximately 2000ml blood loss during revision surgery.

Manufacturer Narrative

Event description: it was reported that the patient has raised legal case to claim the compensation for the damages caused to the patient in the following event.Patient underwent an initial hip arthroplasty on (b)(6), 2010 due to severe osteoarthritis and hip pain.The patient underwent a revision surgery on (b)(6), 2018 due to multiple complications which were as follows: - aseptic lymphocyte-dominant vasculitis- associated lesion (alval) - pelvic ring fracture (patient bone fracture) - hip muscle weakness and muscle destruction related to alval.- cobalt and chromium ion reaction - type 4 - large pseudocyst with approximately a liter of fluid that was slightly green-tinged consistent with alval - extensive trunnionosis with a blackened trunnion - fibrous component on the acetabular component and along the pelvis ring fracture.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.- surgical report: medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent an initial right total hip arthroplasty on (b)(6) 2010.Zimmer biomet components were implanted without complications.The patient underwent a revision procedure on (b)(6) 2018 due to failed hip arthroplasty.The patient had alval metal hypersensitivity reaction, muscle weakness, and muscle destruction.The right posterior pelvic ring had fractured.Lab reports indicated elevated cobalt and chromium levels.A large pseudocyst was present with approximately a liter of green-tinged fluid consistent with alval.Extensive trunnionosis with blackened trunnion.All the products were replaced with new zimmer biomet components.No other findings/complications related to the reported event was identified product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: - device purpose: all involved devices are intended for treatment.- product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.- dhr review: review of the device history records identified the following deviations and/or anomalies: - ncr(s): -2 parts were scrapped due to scratched inlay -1 part was scrapped due to due to material distortion in the roundness (dimension deviation) -1 part was scrapped due to z-dimension of the ball height incorrect.Conclusion: it was reported that the patient has raised legal case to claim the compensation for the damages caused to the patient in the following event.Patient underwent an initial hip arthroplasty on (b)(6), 2010 due to severe osteoarthritis and hip pain.The patient underwent a revision surgery on (b)(6), 2018 due to multiple complications which were as follows: - aseptic lymphocyte-dominant vasculitis- associated lesion (alval) - pelvic ring fracture (patient bone fracture) - hip muscle weakness and muscle destruction related to alval.- cobalt and chromium ion reaction - type 4 - large pseudocyst with approximately a liter of fluid that was slightly green-tinged consistent with alval - extensive trunnionosis with a blackened trunnion - fibrous component on the acetabular component and along the pelvis ring fracture 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.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.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.All the products were returned for investigation; the adapter is still assembled with the head.The articulation surface of the cup shows scratches and opaque areas most likely due to wearing.The surface of the cup on the acetabular side shows signs of bone ongrowth.Around the rim of the cup, it is possible to see that the coating is delaminating.The surface of the head facing the stem presents some dents and scratches.The articulation surface of the head is inconspicuous.The inner surface of the adapter in contact with the head presents surface changes that could point to fretting-corrosion.Green areas are present most likely due to oxidation of the metal.A device history record review identified no deviations or anomalies that could be related to the reported event.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.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.

• Brand Name: ZIMMER MMC, CUP, UNCEMENTED, 54 MM/46 MM, CODE L
• Type of Device: ZIMMER MMC CUP
• 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: 11855226
• MDR Text Key: 251894965
• Report Number: 0009613350-2021-00232
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 01.00634.054
• Device Lot Number: 2528363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2009
• 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: 65 YR
• Patient Sex: Male