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

Catalog Number	550036100
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that polys would not fit.The product were defective.Doe: (b)(6) 2024.Affected side: unknown shoulder.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : it was reported that polys would not fi.The product were defective.Doe: (b)(6) 2024.Affected side: unknown shoulder.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that the reverse liner 36+0 r was found deformed from the locking gap, this condition appears to have been caused by a excessive force when placing the implant onto the reverse humeral shell s 32+8.It is reasonable to conclude that the deformation occurred because the toothed part of the implant was placed first, contrary to what the surgical technique mentioned; align the lateral mark on the reverse liner with the lateral mark on the reverse humeral shell.Place the lateral toe of the reverse liner into the lateral undercut on the reverse humeral shell.Next, with finger pressure, snap the medial edge of the reverse liner into place.Utilizing the impactor handle and convex impactor tip, impact the reverse liner to ensure full seating.Surgical technique 500992014 rev b.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was performed and it can be observed that the device fits with the mating device.However, it requires more force to achieve a proper fit, as the locking gap is already deformed.The overall complaint was confirmed as the observed condition of the reverse liner 36+0 r would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : quantity manufactured: (b)(4), 2) date of manufacture: 2022-10-11, 3) any anomalies or deviations identified in dhr: no-non conformances were identified.4) expiry date: 2027-09-30, 5) ifu reference: 0900-00-128.
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 which 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.H10 additional narrative: 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
Additional information received states that there were no adverse events.
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 is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: REVERSE LINER 36+0 R
• Common Device Name: 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: 18534891
• Report Number: 1818910-2024-01286
• Device Sequence Number: 18066801
• Product Code: PHX
• UDI-Device Identifier: 10603295546788
• UDI-Public: 10603295546788
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K212737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 550036100
• Device Lot Number: MI124766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 01/18/2024; 02/27/2024; 03/19/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 01/22/2024; 02/28/2024; 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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
• Patient Sex: Unknown