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

Model Number N/A

Device Problems Material Erosion (1214); Insufficient Information (3190)

Patient Problem No Information (3190)

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 - 04739, 0001825034 - 2019 - 04841, 0001825034 - 2019 - 04842.

Event Description

It was reported by the 411 group that the patient has underwent an initial left hip arthroplasty on an unknown date.Subsequently, the patient underwent a revision surgery on an unknown date in (b)(6) 2019 due to unknown reasons.All components were removed and replaced with competitors product.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.Event date- unknown day in (b)(6) 2019.Explant date- unknown day in (b)(6) 2019.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: eccentric position of the femoral head within the acetabular cup reflecting moderate liner wear.Small areas of osteolysis in gruen zone 1 of the femoral component.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

It was reported by that the patient has underwent an initial left hip arthroplasty on an unknown date.Subsequently, the patient underwent a revision surgery due to unknown reasons.All components were removed and replaced with competitors product.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: UNK LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9238693
• MDR Text Key: 163887560
• Report Number: 0001825034-2019-04840
• Device Sequence Number: 1
• Product Code: KWZ
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1
• Treatment: UNK CUP CAT#NI LOT#NI; UNK HEAD CAT#NI LOT#NI; UNK STEM CAT#NI LOT#NI
• Patient Outcome(s): Hospitalization; Required Intervention