MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL ANCHOR PEG GLENOID 48MM; GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID

Model Number	1136-42-025
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Revision of right total shoulder due to poly wear.Original dos was over 20 years ago.Doi: 20 years ago, dor: (b)(6) 2021, right shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information received indicated that the adverse consequences were that patient needed revision to reverse total shoulder due to poly wear on the glenoid component.No delay or extended surgery time.This was not a natural progression.The lot number of glenoid was illegible due to poly wear.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination, therefore unavailable for a physical evaluation.However a photograph was provided.Upon visual inspection of the photograph, it was noticed that the photo does not depict the product that is part of the allegation.Therefore, the complaint cannot be confirmed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: GLOBAL ANCHOR PEG GLENOID 48MM
• Common Device Name: GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12638518
• Report Number: 1818910-2021-22791
• Device Sequence Number: 3452047
• Product Code: KWS
• UDI-Device Identifier: 10603295006985
• UDI-Public: 10603295006985
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K981487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1136-42-025
• Device Catalogue Number: 113642025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 10/14/2021; 11/29/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 10/20/2021; 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GLOBAL ADVANTAGE HUM HD 48X21; GLOBAL ADVANTAGE STEM 14 MM; GLOBAL ANCHOR PEG GLENOID 48MM; GLOBAL ADVANTAGE HUM HD 48X21; GLOBAL ADVANTAGE STEM 14 MM; GLOBAL ANCHOR PEG GLENOID 48MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 115 KG