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

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Local Reaction (2035); Swelling (2091); Tissue Damage (2104); Joint Dislocation (2374); Ambulation Difficulties (2544); Osteopenia/ Osteoporosis (2651)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 03933.

Event Description

It was reported patient had initial right total hip arthroplasty.Subsequently, the patient¿s head and liner were revised approximately 6 years later due to recurrent dislocations.The patient presented with increasing pain, swelling, difficulty ambulating, and recurrent dislocations after revision.The patient underwent second revision approximately 15 years post first revision, during which altr, pseudocapsule, bone loss, and poly wear was noted.It was also noted that one of the cerclage wires had corroded due to rubbing against the implants.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed with medical records provided.Revision operative notes demonstrate patient was revised due to altr.Large egress of thick brown fluid noted, approximately 1.5l evacuated from the thigh, pseudocapsule identified and removed.Bone loss of 12-14cm from the shoulder of the prosthesis.Corrosion noted on the stem from the cerclage cable rubbing against it.Femoral head removed without difficulty, no corrosion noted at the taper, femoral component left in place.Cup left in place and well-fixed, locking ring replaced.The previous liner had significant wear posterior superiorly, likely contributing to recurrent dislocations.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 ¿ 00279, 0001825034 - 2020 - 00280, 0001825034 - 2019 - 03933, 0001825034 - 2019 - 03932.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: UNKNOWN LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8973324
• MDR Text Key: 156879378
• Report Number: 0001825034-2019-03932
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2019
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN CUP; UNKNOWN HEAD; UNKNOWN STEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 75