MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 REVERSE LINER 36+0 R; SHOULDER IMPLANT - HUMERAL CUP

Catalog Number 550036100

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Joint Dislocation (2374); Joint Laxity (4526)

Event Date 04/17/2024

Event Type  Injury  

Event 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.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.1.Quantity of manufactured- (b)(4).2.Date of manufacturing- 2022-08-30 (per the label control form).3.Ant anomalies or deviations identified in dhr- i reviewed the manufacturing dhr¿s and did not identify any anomalies or deviations.There were some scrapped parts at the machine operation due to engraving not being deep enough and at the finishing operation due to material finish.These are not outside of normal manufacturing practice.All inspection documents have been reviewed and meet defined requirements.4.Expiry date- 2027-07-31.5.Ifu reference- no physical ifu referenced on packaging specification outside of what was on the label.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 : 1.Quantity of manufactured- (b)(4).2.Date of manufacturing- 2022-08-30 (per the label control form).3.Ant anomalies or deviations identified in dhr- i reviewed the manufacturing dhr¿s and did not identify any anomalies or deviations.There were some scrapped parts at the machine operation due to engraving not being deep enough and at the finishing operation due to material finish.These are not outside of normal manufacturing practice.All inspection documents have been reviewed and meet defined requirements.4.Expiry date- 2027-07-31 5.Ifu reference- no physical ifu referenced on packaging specification outside of what was on the label.

• Brand Name: REVERSE LINER 36+0 R
• Type of Device: SHOULDER IMPLANT - HUMERAL CUP
• 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: 19212964
• MDR Text Key: 341386115
• Report Number: 1818910-2024-09445
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295546788
• UDI-Public: 10603295546788
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 550036100
• Device Lot Number: MI124724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GLENOSPHERE 36+8; REVERSE HUMERAL SHELL L 40+0
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR