MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EMSYS LNR AOX ELV 52X40; HIP IMPLANT : ACETABULAR LINER

Catalog Number	472252240
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
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 the liner was damaged during trial reduction.Unknown surgical delay.Affected side: left hip.
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.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: no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary it was reported that the liner was damaged during trial reduction.Unknown surgical delay.Affected side: left hip.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned sample revealed there were no product problems observed with emsys lnr aox elv 52x40.The device exhibits extraction damage.The investigation was not bale to confirm the reported event.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was unconfirmed as the observed condition of the emsys lnr aox elv 52x40 would not contribute to the alleged device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: EMSYS LNR AOX ELV 52X40
• Common Device Name: HIP IMPLANT : ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17624090
• Report Number: 1818910-2023-17571
• Device Sequence Number: 20658455
• Product Code: LPH
• UDI-Device Identifier: 10603295501343
• UDI-Public: 10603295501343
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K221636
• 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): 08/25/2023

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: 472252240
• Device Lot Number: 3869483
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 09/13/2023; 09/28/2023; 12/19/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 09/13/2023; 09/29/2023; 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2023
• 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