MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 28MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136528320

Device Problem Difficult to Insert (1316)

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

Event Date 01/15/2024

Event Type  malfunction  

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 (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

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

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.

• Brand Name: DELTA CER HEAD 12/14 28MM +5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18552372
• MDR Text Key: 333363426
• Report Number: 1818910-2024-01512
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033288
• UDI-Public: 10603295033288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• 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: 136528320
• Device Lot Number: 4293899
• 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: 10/09/2023
• 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: BI MENTUM ALTRX LNR 47 28.
• Patient Age: 70 YR
• Patient Sex: Female