MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENDER SOLUTIONS MALE (GSM) FEMORAL COMPONENT; PROSTHESIS KNEE

Model Number N/A

Device Problem Migration (4003)

Patient Problem Necrosis (1971)

Event Date 12/17/2018

Event Type  Injury  

Event Description

It was reported patient underwent a revision procedure ten months post implantation due to necrosis and subsidence.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

(b)(4).Implant date: (b)(6) 2013.Date of event, explant date, concomitant medical products: (b)(6) 2013.Medical product: nonporous tibial baseplate catalog # 630800301 lot # unknown rotating platform articular surface ultra congruent size 0 left 13 mm height catalog # 00543201013 lot # unknown.All poly patella size 1 8 mm thickness catalog # 00542000801 lot # unknown.Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filled for this event: 0001822565 - 2022 - 01376.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the initial medwatch.Updated: b3, b4, b5, d4, d6a, d6b, d10, e1, g3, g6, h1, h2, h4 d10: nonporous tibial baseplate catalog # 630800301 lot # 61994466 rotating platform articular surface ultracongruent catalog # 00543201013 lot # 61114274 all poly patella catalog # 00542000801 lot # 61796942.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6: suggested code: mechanical code g4: femur.Reported event was unable to be confirmed due to limited information received from the customer.Device was not returned.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.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 available at the time of this report.

• Brand Name: GENDER SOLUTIONS MALE (GSM) FEMORAL COMPONENT
• Type of Device: PROSTHESIS KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• 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: 14353512
• MDR Text Key: 291359638
• Report Number: 0001822565-2022-01373
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K173057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00541201601
• Device Lot Number: 62128265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2012
• 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): Required Intervention; Hospitalization