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

Model Number N/A

Device Problems Unstable (1667); Naturally Worn (2988)

Patient Problems Adhesion(s) (1695); Pain (1994); Scar Tissue (2060)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient was revised due to failed hip arthroplasty.Patient was experiencing pain and instability.Pre operative images identified eccentric positioning of the right femoral head and osteolysis in zones 1-3 of acetabulum and proximal femoral region.The acetabular liner was worn superiorly.Significant scarring of the capsule was observed.The locking ring, liner, and head were replaced.No other findings related to the event were noted.Part and lot identification are necessary for review of device history records, neither were provided.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 - 2020 - 03951.0001825034 - 2020 - 03952.0001825034 - 2020 - 03954.

Event Description

It was reported the patient underwent right total hip arthroplasty.Subsequently, patient underwent a revision procedure approximately 21 years later due to pain, instability, implant wear and osteolysis.The head and liner components were removed and replaced.Cup and stem were retained.No further event information available at the time of this report.

• Brand Name: UNKNOWN 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: 10762637
• MDR Text Key: 213894049
• Report Number: 0001825034-2020-03953
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 10/19/2020
• 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 Sequence Number: 1
• Treatment: ITEM# NI NAME UNK RNGLOC LOT# NI
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 91