MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US XTNDGLENO ECCD38MM+0MM SHRTPST; DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE

Model Number	1307-61-038
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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
The patient was revised to address pain with rom.Surgeon determined there was scapular notching and impingement, suggesting the patient needed more lateralization.He revised the glenosphere to a plus 6 and changed out the humeral poly insert.There was no loosening of the components and no deficiency noted with the implants.There was no delay in the procedure.Doi: (b)(6) 2020, dor: (b)(6) 2021, right shoulder.

• Brand Name: XTNDGLENO ECCD38MM+0MM SHRTPST
• Common Device Name: DELTA XTEND IMPLANTS : SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12370087
• Report Number: 1818910-2021-18703
• Device Sequence Number: 4015072
• Product Code: KWS
• UDI-Device Identifier: 10603295502593
• UDI-Public: 10603295502593
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/06/2021

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: 1307-61-038
• Device Catalogue Number: 130761038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/26/2021
• 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: DXTEND STAND PE CUP D38 +6MM; XTNDGLENO ECCD38MM+0MM SHRTPST
• Outcome Attributed to Adverse Event: Required Intervention