MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK LINER; PROTHESIS, SHOULDER

Model Number N/A

Device Problems Detachment Of Device Component (1104); Unstable (1667); Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); No Information (3190)

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional concomitant medical products: glenosphere 40 mm diameter part # 00434904011, lot # 63356372; humeral stem spacer size 12 mm part # 00434903912, lot # unk.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-05228, 0001822565-2017-05234.It is unknown if the product will 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.

Event Description

It was reported that patient had revision surgery due to dislocation with disassociation of polyethylene liner and custom spacer was implanted with new retentive liner and glenosphere.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not 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 that the patient underwent a right total shoulder arthroplasty revision due to instability, dislocation, tissue laxity, and disassociation of the polyethylene liner.A new retentive liner, thicker spacer, and new glenosphere were implanted.

• Brand Name: UNK LINER
• Type of Device: PROTHESIS, SHOULDER
• 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: 7082709
• MDR Text Key: 94827884
• Report Number: 0001822565-2017-07880
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 109