MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US XTNDGLENO ECCD42MM+0MM SHRTPST; SHOULDER GLENOSPHERE

Model Number	1307-61-042
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
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 glenospheres wouldn¿t thread into metaglene.No surgical delay.Doe: (b)(6) 2021 right shoulder.
Additional Manufacturer Narrative
Product complaint # (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.Device history lot: a manufacturing record evaluation was performed for the finished device d20081147 as part of this investigation and no non-conformances/manufacturing irregularities were identified.

• Brand Name: XTNDGLENO ECCD42MM+0MM SHRTPST
• Common Device Name: SHOULDER GLENOSPHERE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12513949
• Report Number: 1818910-2021-20795
• Device Sequence Number: 3913394
• Product Code: PHX
• UDI-Device Identifier: 10603295502609
• UDI-Public: 10603295502609
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K183077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 09/01/2021

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 Model Number: 1307-61-042
• Device Catalogue Number: 130761042
• Device Lot Number: D20081147
• 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: 09/01/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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: UNKNOWN SHOULDER METAGLENE.; XTNDGLENO ECCD42MM+0MM SHRTPST.; XTNDGLENO ECCD42MM+0MM SHRTPST.; UNKNOWN SHOULDER METAGLENE; XTNDGLENO ECCD42MM+0MM SHRTPST; XTNDGLENO ECCD42MM+0MM SHRTPST
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 91 KG