MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 BI MENTUM ALTRX LNR 47 28; HIP IMPLANT - ACETABULAR LINER

Catalog Number 122128047

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2024

Event Type  malfunction  

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 Description

A surgeon was performing a total hip replacement using our bimentum dual mobility system for the acetabular portion.When compressing the inner 28mm head into the 47/28 bimentum liner there were two audible pops as normal and the inner head was moving freely inside the liner as it should.This was done by the surgeon himself who has done many of these cases using these specific implants.Once the head was impacted onto the stem he noticed it was moving more than usual.The implant sizes and expirations were double checked and everything was normal on that end.The liner seemed to not be fitting the head correctly and like there was more space than usual.I called my manager and shared a video to confirm if he knew if this was normal and he double checked with another surgeon.Neither could confirm if the implants were okay or not so we decided to remove them and open a new head and liner.The surgeon did not think the new head and liner were preforming strangely like the previous ones were so we completed the case.Was surgery delayed due to the reported event? yes, if yes, number of minutes: 5, action taken when event occurred? both implants were removed and new ones were opened to replace the previous ones, was procedure successfully completed? yes, were fragments generated? no.

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.

Event Description

Additional information was received stating that there was no patient harm.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary according to the information received: a surgeon was performing a total hip replacement using our bimentum dual mobility system for the acetabular portion.When compressing the inner 28mm head into the 47/28 bimentum liner there were two audible pops as normal and the inner head was moving freely inside the liner as it should.This was done by the surgeon himself who has done many of these cases using these specific implants.Once the head was impacted onto the stem he noticed it was moving more than usual.The implant sizes and expirations were double checked and everything was normal on that end.The liner seemed to not be fitting the head correctly and like there was more space than usual.I called my manager and shared a video to confirm if he knew if this was normal and he double checked with another surgeon.Neither could confirm if the implants were okay or not so we decided to remove them and open a new head and liner.The surgeon did not think the new head and liner were preforming strangely like the previous ones were so we completed the case.The product was not returned to depuy synthes, however photos were provided for review.See attachments (img_3097.Mov, img_3100.Mov and img_3101.Jpeg).The photo/video investigation revealed that bi mentum altrx lnr 47 28 and delta cer head 12/14 28mm +5 appears to not properly match between them.A manufacturing records review was performed and no non-conformances was found.Therefore, with evidence provided a potential cause could not be established.Since the device was not returned, a dimensional inspection and a functional test cannot be performed.The overall complaint was confirmed as the observed condition of the bi mentum altrx lnr 47 28 would contribute to the complained device issue.Based on the investigation findings, 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 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 a manufacturing record evaluation was performed for the finished device 3981172 number, and no non-conformances/manufacturing irregularities were identified.Review of the device history records found that the lot of 28 parts were inspected at an aql of 1.5 and no anomalies were found of the inner profile of the liner.Device history review a manufacturing record evaluation was performed for the finished device 3981172 number, and no non-conformances/manufacturing irregularities were identified.

• Brand Name: BI MENTUM ALTRX LNR 47 28
• Type of Device: HIP IMPLANT - ACETABULAR LINER
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18552368
• MDR Text Key: 333454489
• Report Number: 1818910-2024-01511
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295525349
• UDI-Public: 10603295525349
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 122128047
• Device Lot Number: 3981172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• 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: DELTA CER HEAD 12/14 28MM +5
• Patient Age: 70 YR
• Patient Sex: Female