MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RETENTIVE POLY LINER PLUS OFFSET; PROSTHESIS, SHOULDER

Catalog Number 00434906506

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical devices: unk stem, cat#: ni, lot#: ni.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdrs were associated with this event, please see associated reports: 0001822565 - 2020 - 02800.

Event Description

It was reported the patient underwent a total shoulder arthroplasty.Subsequently, the patient was revised two weeks later due to disassociation of the poly liner from the stem.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.D4: udi: (b)(4).Visual examination of the returned product identified: heavy gouge near anti-rotational slot.Both sides of the poly liner exhibit heavy wear.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.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.

Event Description

No further event information is available at the time of this report.

• Brand Name: RETENTIVE POLY LINER PLUS OFFSET
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10378256
• MDR Text Key: 202002234
• Report Number: 0001822565-2020-02798
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K121543
• 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: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00434906506
• Device Lot Number: 64008390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention