MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RETENTIVE POLY LINER PLUS (+) 3 MM OFFSET 36 MM DIAMETER 65 DEGREE NECK ANGLE; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical product: catalog #: 00434901813, humeral stem 18 mm stem, lot # 63102455.Complaint was considered confirmed via visual examination of the returned products identified damages around the scallops and various locations.Damages consist of nicks, gouges, scratches and deformation.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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: 0001822565-2020-01633 and 0001822565-2020-01634.

Event Description

It was reported the patient underwent a shoulder arthroplasty on approximately two (2) months ago.Subsequently, the patient was revised about a month later due to the poly disassociated from stem.During the procedure two (2) polys were attempted and both would not lock.Both retentive.Finally a standard poly was used and locked in place.

• Brand Name: RETENTIVE POLY LINER PLUS (+) 3 MM OFFSET 36 MM DIAMETER 65 DEGREE NECK ANGLE
• Type of Device: PROSTHESIS 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: 10609374
• MDR Text Key: 209256331
• Report Number: 0001822565-2020-03388
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024269187
• UDI-Public: (01)00889024269187
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00434906503
• Device Lot Number: 63500073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1