MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 METAGLENE LONG PEG +15MM; SHOULDER METAGLENE

Model Number	140760025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
The patient was revised to address instability.No surgical delay is noted.Doi: (b)(6) 2020.Dor: (b)(6) 2020; 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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: METAGLENE LONG PEG +15MM
• Common Device Name: SHOULDER METAGLENE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10491937
• Report Number: 1818910-2020-19478
• Device Sequence Number: 16992907
• Product Code: HSD
• UDI-Device Identifier: 10603295423652
• UDI-Public: 10603295423652
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K192855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2020

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: 140760025
• Device Catalogue Number: 140760025
• Device Lot Number: 5326768
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 10/09/2020
• 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 HUMERAL SPACER +9MM; DXTEND HUMERAL SPACER +9MM; DXTEND HUMERAL SPACER +9MM; DXTEND STAND PE CUP D42 +9MM; XTND GLENO ECC D42MM +8MM
• Outcome Attributed to Adverse Event: Required Intervention