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

Model Number N/A

Device Problem Naturally Worn (2988)

Patient Problems Osteolysis (2377); Osteopenia/ Osteoporosis (2651); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown stem, unknown cup, unknown head.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 underwent an initial hip arthroplasty on an unknown date.Subsequently, the patient was revised due to poly wear.Attempts have been made and additional information on the reported event is unavailable.

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.Reported event was confirmed with x rays received.Review of the available records identified the following: the left hip is anatomically aligned.There was marked eccentric position of right femoral head within acetabular cup reflecting severe poly wear.Abnormal radiolucency reflecting osteolysis of the femoral component was observed.The bones were osteopenic.There was possible osteolysis along the superior aspect of cup.No other issues were identified.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.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: 0001822565 - 2019 - 04062.

• 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: 8909909
• MDR Text Key: 154855169
• Report Number: 0001822565-2019-03556
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN LINER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention