MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A-MAGNUM 52-60MM TPR INSRT-6; PROSTHETIC, HIP

Model Number N/A

Device Problems Material Erosion (1214); Separation Problem (4043)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 09/29/2021

Event Type  Injury  

Event Description

It was reported pt underwent a revision procedure approximately 14 years post-implantation due to pain and increased metal ions.During the revision surgery, black synovial tissue was found, the taper adapter was cold welded to the stem, loose acetabular cup with no bony growth posteriorly and black discoloration to the acetabular bone were also found.All components were exchanged without complications.There is no additional information available at the time of this report.

Manufacturer Narrative

(b)(4).Concomitant medical products: us157862 m2a-magnum pf cup 62odx56id lot number 171630.157456 m2a-magnum mod hd sz 56mm lot number 871850.X11-180318 bi-metric/x por nc lat 18x170 lot number 953140.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-00677.0001825034-2023-00675.0001825034-2023-00674.The device will not be returned for analysis as it¿s location is not known; however, an investigation of the reported event is in progress.Once the investigation is completed, as supplemental medwatch will be submitted device location is unknown.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 d4: expiration date g3 g6 h2 h4 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.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left hip tha was performed on (b)(6), 2007.A revision occurred on (b)(6), 2021 due to pain and elevated metal ions.During the revision, the tissues were blackish in color and the taper adaptor was cold welded to the stem.Additionally, the cup was loose with no bony ingrowth.All implants but the stem were explanted with new ones placed.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: M2A-MAGNUM 52-60MM TPR INSRT-6
• Type of Device: PROSTHETIC, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16631881
• MDR Text Key: 312195074
• Report Number: 0001825034-2023-00676
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

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: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 139264
• Device Lot Number: 531940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 70 YR