MAUDE Adverse Event Report: ZIMMER BIOMET, INC.

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Failure of Implant (1924); Synovitis (2094); Metal Related Pathology (4530); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: unknown magnum cup.Multiple reports were submitted along with this report 0001825034-2021-02638.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.

Event Description

It was reported that the patient was revised due to metallosis approximately 10 years post implantation.Attempts have been made and additional information on the reported event is unavailable.

Event Description

It was reported that the patient was revised due to elevated metal ions approximately 10 years post implantation.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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.

Event Description

It was reported that the patient underwent a right hip revision approximately 12 years post implantation due to elevated metal ions.During the procedure, metallosis, synovitis and cysts were noted.All components were exchanged without complications.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a2; b4; b5; b7; d1; d2; d4; d6a; d10; g2; g3; g4; h2; h4; h6.Corrected: d6b.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.The dhr was reviewed, and no manufacturing deviations or anomalies were found.The reported products were also reviewed for compatibility with no issues werer noted.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the following reported issues: trunnion appears to have minimal wear and debris cleaned, stem well fixed, diffuse synovitis, and metal stain tissue with acetabulum removal.Rom stable, with no complications.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.

Event Description

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

• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12445754
• MDR Text Key: 270512605
• Report Number: 0001825034-2021-02635
• Device Sequence Number: 1
• Product Code: KWA
• 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: Consumer,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/09/2023
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 11/09/2021; 10/17/2022; 01/06/2023
• Supplement Dates FDA Received: 11/19/2021; 11/14/2022; 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2009
• 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: CAT #:139252 MA2TAPER ADAPTER LOT#, 700090.; CAT#: 1103205 TAPERLOC FEMORAL LOT#: 030450.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female