MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN M2A LINER PROSTHESIS, HIP

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)

Event Date 06/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). No product was returned or pictures provided; visual and dimensional evaluations could not be performed. Part and lot identification are necessary for review of device history records, neither were provided. Medical records/radiographs were provided and reviewed by a health care professional. A review of the available records identified findings of the reported issues. The op records indicate lysis, elevated chromium levels, tendon tear, pain, limping, metallosis, tumor, and bone loss as reported. No complications were noted in the op record. 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.   multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02175, 0001825034 - 2021 - 02174.

Event Description

It was reported a patient underwent an initial right total hip arthroplasty performed on an unknown date. Subsequently, the patient underwent revision of all components approximately ten (10) years post implantation due to pain, tissue damage, and metallosis. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNKNOWN M2A LINER
• Type of Device: PROSTHESIS, HIP
• 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: 12703817
• MDR Text Key: 278561646
• Report Number: 0001825034-2021-02933
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Treatment Data

Date Received: 10/27/2021 Patient Sequence Number: 1

Treatment

UNKNOWN M2A STEM