MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 REVERSE LINER 40+4 R; SHOULDER IMPLANT - HUMERAL CUP

Catalog Number	550040104
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 after the patient had their original shoulder done, the shoulder become dislocated.According to surgical implant records, the patient was implanted with a 40+8 glenosphere, medium +8 shell, and a 40 +4 retentive poly.With that construct pretty much maxed out, the surgeon felt the patient's humeral components would need to be revised as a whole.The humeral stem was removed and the patient was then prepped for a biomet humeral component.With the baseplate well fixed, the surgeon opted to leave it and place a 40+8 eccentric glenosphere.Once the biomet prep was complete, the shoulder was reduced and put through a full range of motion and found to be stable.Doi: (b)(6) 2023; dor: (b)(6) 2024; affected side: right shoulder.
Event or Problem Description
Additional information was received and states that : no surgical delay to report.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.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 records evaluation (mre) was not perform 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 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: REVERSE LINER 40+4 R
• Common Device Name: SHOULDER IMPLANT - HUMERAL CUP
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20751090
• Report Number: 1818910-2024-24321
• Device Sequence Number: 12741155
• Product Code: PHX
• UDI-Device Identifier: 10603295546498
• UDI-Public: (01)10603295546498(17)20270531(10)MI124572
• 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: 2023
• Device Explanted 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,Followup

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: 550040104
• Device Lot Number: MI124572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 12/03/2024; 12/05/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/04/2024; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2022
• 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: GLENOSPHERE 40+8.; REVERSE HUMERAL SHELL M 36+8.; SHORT STEM M 36.; UNKNOWN BASEPLATE INHANCE.; UNKNOWN GLENOSPHERE INHANCE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male