MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH 2/14-18/20; DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

Model Number N/A

Device Problems Output Problem (3005); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 05/21/2020

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.Medical product: zimmer mmc, cup, uncemented, 52 mm/44 mm, code j; item# : 0100634052; lot# : 2528453.Metasul ldh, head, 44, code j, taper 18/20; item# : 0100181440; lot# : 2437106.Femoral stem fiber metal taper collarless 12/14 neck taper with calcicoat ceramic coating size 11 standard body standard neck offset; item# : 65786201100; lot# : 55969500.Therapy date: (b)(6) 2020.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.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 right side.Subsequently, underwent revision surgery due to pain, elevated metal ions, trunnionosis, and tissue damage.The stem remained intact, and all other components were replaced without complication.

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.D10: medical product: zimmer mmc, cup, uncemented, 52 mm/44 mm, code j; catalog#: 01.00634.052; lot#: 2528453.Metasul ldh, head, 44, code j, taper 18/20; item# 0100181440; lot#2437106.Femoral stem fiber metal taper collarless 12/14 neck taper with calcicoat ceramic.Coating size 11 standard body standard neck offset; catalog#: 65786201100; lot#: 55969500.Therapy date: may 21, 2020.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 (medical records) 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).

Event Description

Patient was revised due to pain, elevated metal ions, trunnionosis and tissue damage.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the patient was received total hip arthroplasty on (b)(6) 2010.Subsequently, underwent revision surgery on (b)(6) 2020 due to pain, elevated metal ions, trunnionosis, and tissue damage.The stem remained intact, and all other components were replaced without complication.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: review of the provided medical records found the patient had high cobalt and chromium, with the levels systematically rising.During the revision surgery, a large bursa filled with gray stained cloudy fluid consistent with metal debris was found.The staining tracked down to the joint and in the soft tissues.There were longitudinal tears in the gluteus medius tendon and significant corrosion on the taper of the trunnion.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 product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that the patient was received total hip arthroplasty on (b)(6) 2010.Subsequently, underwent revision surgery on (b)(6) 2020 due to pain, elevated metal ions, trunnionosis, and tissue damage.The stem remained intact, and all other components were replaced without complication.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.

• Brand Name: 2/14-18/20
• Type of Device: DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 12358483
• MDR Text Key: 267824820
• Report Number: 0009613350-2021-00417
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K053536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2013
• Device Model Number: N/A
• Device Catalogue Number: 01.00185.146
• Device Lot Number: 2486176
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention