MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 GLENOSPHERE 36+8; SHOULDER IMPLANT - GLENOSPHERE

Catalog Number	550536008
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that patient was revised due to dislocation.Patient had original surgery done at hospital on (b)(6) 2024.Unfortunately they dislocated and needed to be revised.Surgeon removed the poly, shell, and glenosphere.A bigger glenosphere was implanted to increase stability.There was no adverse events or delays took place.Doi: (b)(6) 2024.Dor: unknown.Affected side: left shoulder.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Product description:- 550536008.Product code:- glenosphere 36+8.Lot no:- 333112.Quantity manufactured:- (b)(4) pieces.Date of manufacturing:- finished production ¿ 9/12/2022, micropulse clean/pack ¿ 10/31/2022, sterigenics ¿ 11/3/2022.Released from m.P.On 11/7/2022.Any anomalies or deviations identified in dhr:- started product with (b)(4) pieces with 2 pieces scrapped at set-up at first mill operation.Finished the rest of the operations with no scrap and no quality issues for a finished total of (b)(4) pieces.Expiry date:-- n/a ¿ micropulse label states 8/31/2027.Ifu reference:- n/a.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: product description:- 550536008.Product code:- glenosphere 36+8.Lot no:- 333112.Quantity manufactured:- (b)(4) pieces.Date of manufacturing:- finished production ¿ 9/12/2022, micropulse clean/pack ¿ 10/31/2022, sterigenics ¿ 11/3/2022.Released from m.P.On 11/7/2022 any anomalies or deviations identified in dhr:- started product with (b)(4) pieces with 2 pieces scrapped at set-up at first mill operation.Finished the rest of the operations with no scrap and no quality issues for a finished total of (b)(4) pieces.Expiry date:-- n/a ¿ micropulse label states 8/31/2027.Ifu reference:- n/a.Device history batch: a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities were identified.

• Brand Name: GLENOSPHERE 36+8
• Common Device Name: SHOULDER IMPLANT - GLENOSPHERE
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19212987
• Report Number: 1818910-2024-09446
• Device Sequence Number: 6942167
• Product Code: PHX
• UDI-Device Identifier: 10603295546696
• UDI-Public: 10603295546696
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/30/2024

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 Catalogue Number: 550536008
• Device Lot Number: 333112
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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: REVERSE HUMERAL SHELL L 40+0; REVERSE LINER 36+0 R
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Unknown