MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL UNITE HEAD 52X21 ECC; GLOBAL UNITE IMPLANTS : HUMERAL TRIALS

Model Number	1100-52-620
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	01/26/2021
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
It was reported that the patient had a total shoulder at (b)(6) hospital on (b)(6) 2020.He complains of shoulder joint pain and instability.So he went to rush to have his shoulder revised by the surgeon.Also, it was reported that the glenoid had loosening at the bone to cement interface.Depuy cement was used.No report of fall or any other incident.No surgical delay.Doi: (b)(6) 2020, dor: (b)(6) 2021, left shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: GLOBAL UNITE HEAD 52X21 ECC
• Common Device Name: GLOBAL UNITE IMPLANTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11286314
• Report Number: 1818910-2021-02482
• Device Sequence Number: 3842889
• Product Code: HSD
• UDI-Device Identifier: 10603295004745
• UDI-Public: 10603295004745
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1100-52-620
• Device Catalogue Number: 110052620
• Device Lot Number: HY7136
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CROSSLINK ANCHOR PG GLENOID 48; DEPUY1 GENTAMICIN CEMENT 40G; GLOBAL UNITE HEAD 52X21 ECC; CROSSLINK ANCHOR PG GLENOID 48; DEPUY1 GENTAMICIN CEMENT 40G; GLOBAL UNITE HEAD 52X21 ECC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR