MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 XTNDGLENO ECCD38MM+0MM SHRTPST; GLENOSPHERE

Model Number	1307-61-038
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/13/2021
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 was complaining of pain after picking up a case of soda.With conservative treatment, the pain did not subside.During the revision exploration, it was found that the glenosphere was loose and it was removed.The metaglene was checked and all components were stable.A 38+2 glenosphere was implanted and a 38+9 cup was trialed.The surgeon added a +9mm spacer and a 38+3 cup.The patient was stable with these components and they were implanted.Doi: (b)(6) 2020.Dor: (b)(6) 2021.Right shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was 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 : 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: XTNDGLENO ECCD38MM+0MM SHRTPST
• Common Device Name: GLENOSPHERE
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11891568
• Report Number: 1818910-2021-11329
• Device Sequence Number: 11110043
• Product Code: KWS
• UDI-Device Identifier: 10603295502593
• UDI-Public: 10603295502593
• 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
• 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): 05/13/2021

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: 1307-61-038
• Device Catalogue Number: 130761038
• Device Lot Number: D19060770
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/07/2021
• 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 +9MM; UNKNOWN SHOULDER METAGLENE; XTNDGLENO ECCD38MM+0MM SHRTPST
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR