MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZIMMER MMC, CUP, UNCEMENTED, 52 MM/44 MM, CODE J; HIP PROSTHESIS

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Metal Related Pathology (4530); Insufficient Information (4580)

Event Type  Injury  

Event Description

Patient underwent revision surgery.Legal case: the patient is pursuing a product liability claim.No additional information is currently available.

Manufacturer Narrative

Therapy date: (b)(6) 2020.Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer switzerland manufacturing gmbh legal department is well trained and passes all information concerning the case to our complaint handling department.As soon as supplemental information becomes available an updated report will be submitted.The manufacturer did not receive x-rays, or 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).Neither product nor lot number available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Event description: a new legal claim related to zimmer mmc cup was announced; however, no information was provided.Review of received data: no medical data relevant to the case has been received.No further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: document review could not be performed due to unknown product identification.Device purpose: all zimmer biomet devices are intended for treatment.Product compatibility: the compatibility check could not be performed due to missing product identification.Conclusion: a new legal claim related to zimmer mmc cup was announced; however, no information was provided.Due to the lack of information the announced claim cannot be confirmed.A nonconformance or a complaint out of box (coob) was not identified on the basis of the known data.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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d1, d4, g3, g6, h1, h2, h6, h10 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.Review of the provided medical records identified the following: a patient has had severe pain and problems due to arthritis underwent a left total hip replacement.The consultation report describes that the patient twisted their leg, which was not a dislocation but caused the patient pain and discomfort.Physical examination performed, appears normal and the radiographical findings state that the acetabular and femoral components appear stable.The consultation report, states that the patient has had a popping sensation with certain manoeuvre of flexion abduction and external rotation.Otherwise, no significant problems are mentioned.The patient could be having some degree of instability due to impingement at the extremes of motion or iliopsoas tendonitis.Findings of the mri examination state no bone marrow edema, no acute fracture or subluxation, no periprosthetic fracture, no mri evidence of osteolysis.A periarticular fluid collection is identified posterior to the left hip arthroplasty.No muscular edema or atrophy.The visualized tendons are intact.In conclusion, left total hip arthroplasty with periarticular fluid collection, concerning for adverse tissue reaction.The clinical evaluation performed states that the lab test results together with the mri scan results may indicate a metal reaction around the hip replacement parts, possibly at the head-stem connection.However, a definitive root cause cannot be determined.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

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

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.The head and the adapter were returned for investigation.The articulating surface of the head shows scratches.The bevel of the head shows scratches and dents.The taper of the adapter shows signs of fretting on more than 30% of the surface and aggressive local corrosion attack with corrosion debris.The new available information does not change the outcome of the investigation as a definitive root cause cannot be determined.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, 52 MM/44 MM, CODE J
• 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: 13110462
• MDR Text Key: 283666669
• Report Number: 0009613350-2021-00687
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/12/2023

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: 08/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 01.00634.052
• Device Lot Number: 2522831
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 01/03/2022; 11/01/2021; 09/29/2023
• Supplement Dates FDA Received: 01/25/2022; 11/16/2022; 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2009
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female