MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number	136536710
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/06/2024
Type of Reportable Event	Serious Injury
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
Revision of a pinnacle constrained liner.On friday (b)(6) 2024, we were contacted by the attending physician regarding the dislocation of a hip/liner revision to be done on saturday morning (b)(6) 2024.The patient had a pinnacle constrained liner (1218-36-656, pin lnr neut (b)(4) with a 36mm ceramic head ball (1365-36-710) that had dislocated.Upon review of the x-ray, the head ball was completely out of the liner.The constrained locking ring was still firmly attached to the liner.The removal of the liner was successful with damage to the liner, a new liner and head ball was implanted without incident.
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).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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: according to the information received, revision of a pinnacle constrained liner.On friday (b)(6) 2024, we were contacted by the attending physician regarding the dislocation of a hip/liner revision to be done on saturday morning (b)(6) 2024.The patient had a pinnacle constrained liner (1218-36-656, pin lnr neut +4 36idx56od) with a 36mm ceramic head ball (1365-36-710) that had dislocated.Upon review of the x-ray, the head ball was completely out of the liner.The constrained locking ring was still firmly attached to the liner.The removal of the liner was successful with damage to the liner, a new liner and head ball was implanted without incident.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device and photos were provided for review.See attachment (b)(4).The x-ray investigation revealed that the dlt ts cer hd 12/14 36mm +1.5 was observed dislocated from the liner.A visual inspection of the head reveals no signs of damage.With the information provided is not possible to determine a potential cause at this moment, however in support of the evaluation performed, the observed condition of the dlt ts cer hd 12/14 36mm +1.5 may have been caused by exposure to irregularities in the weight loading of the device and moments generated.The event is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.A dimensional inspection was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the dlt ts cer hd 12/14 36mm +1.5 would contribute to the complained device issue.Based on the investigation findings 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 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 = > product code 136536710, work order (b)(4) was manufactured on 14-dec 2021.(b)(4) parts were manufactured per specification and al raw materials met specification.Scrap: there was no scrap associated with this lot.Reprocessing: there was no material reprocessing reports mrr associated with this lot.Non-conformance: there were no non-conformances associated whit this lot.Corrected: h3.

• Brand Name: DLT TS CER HD 12/14 36MM +1.5
• Common Device Name: 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 IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18519177
• Report Number: 1818910-2024-01004
• Device Sequence Number: 6751356
• Product Code: KWA
• UDI-Device Identifier: 10603295033653
• UDI-Public: 10603295033653
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K073570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 01/16/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 136536710
• Device Lot Number: 3638445
• 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: 01/07/2024
• Supplement Date Received by Manufacturer: 01/22/2024; 01/25/2024; 03/06/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 01/25/2024; 01/26/2024; 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PIN LNR CONS NEUT +4 36IDX56OD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female