MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLOBAL AP HUMERAL HD 44X15 ECC; GLOBAL AP IMPLANTS : SHOULDER HUMERAL HEADS

Model Number	1130-44-600
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/27/2021
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
Surgeon elected to perform a left shoulder revision arthroplasty on a patient who he performed a primary total shoulder arthroplasty on (b)(6) 2010.Surgeon noted that the patient performed well post operatively after her primary shoulder arthroplasty until 2018 when she experience several dislocations.Surgeon did not specify the exact number of dislocations of the left shoulder.Most recent dislocation happened on (b)(6) 2021 and doctor noted they had difficulty reducing the patient¿s shoulder this time but were successful in reducing it.Doi: (b)(6) 2010 dor: (b)(6) 2021.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > the device associated with this report was not received for examination.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 = > lot information not available.

• Brand Name: GLOBAL AP HUMERAL HD 44X15 ECC
• Common Device Name: GLOBAL AP IMPLANTS : SHOULDER HUMERAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12315918
• Report Number: 1818910-2021-17763
• Device Sequence Number: 3181646
• Product Code: HSD
• UDI-Device Identifier: 10603295005872
• UDI-Public: 10603295005872
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K060874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 07/21/2021

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: 1130-44-600
• Device Catalogue Number: 113044600
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/09/2021
• 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 44; GLOBAL AP HUMERAL HD 44X15 ECC; CROSSLINK ANCHOR PG GLENOID 44; GLOBAL AP HUMERAL HD 44X15 ECC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR