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
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog #: 00434901813, humeral stem 18 mm stem, lot #: 63102455.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-01634.Will be returned.
Event or Problem 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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).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: 0001822565-2020-03388.

• Brand Name: RETENTIVE POLY LINER PLUS (+) 3 MM OFFSET 36 MM DIAMETER 65 DEGREE NECK ANGLE
• Common Device Name: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10051279
• Report Number: 0001822565-2020-01633
• Device Sequence Number: 13661779
• Product Code: HSD
• UDI-Device Identifier: 00889024269187
• UDI-Public: 00889024269187
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE