MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR CUP PINNACLE

Catalog Number UNK HIP ACETAB CUP PINN

Device Problem Osseointegration Problem (3003)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Synovitis (2094); Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 01/14/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.H6: component code: appropriate term/code not available (g07002) used to capture no findings available.The size of the article is too large to attach/submit with the 3500a submission.The citation of the article has been provided below: wirries n, becker re, skutek m.Failure of total hip arthroplasty due to delamination and wear of titanium nitride-coated titanium heads: a case series.J orthop case rep.2024 jan;14(1):36-39.Doi: 10.13107/jocr.2024.V14.I01.4138.Pmid: 38292113; pmcid: pmc10823820.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.Investigation summary : no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.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 device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.Device history batch : null.Device history review : null.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: wirries n, becker re, skutek m.Failure of total hip arthroplasty due to delamination and wear of titanium nitride-coated titanium heads: a case series.J orthop case rep.2024 jan;14(1):36-39.Doi: 10.13107/jocr.2024.V14.I01.4138.Pmid: 38292113; pmcid: pmc10823820.Objective and methods: the aim of this study was to present the case studies of three patients requiring revision for premature failure of total hip arthroplasty (tha).All patients received titanium nitride (tin)-coated heads made of titanium alloy tialv as part of their index total hip replacements.At the time of revision surgery, intraoperative findings included partial or complete delamination of the tin head coating and wear/deformation of the tialv heads.This pc will capture the cases involving depuy products.Case 1: 76-year-old female patient received a revision of an unknown hip 9.5 years after primary tha to treat pain, synovitis, loosening of a pinnacle cup and osteolysis.Upon entering the joint, severe metallosis was identified.The titanium coating was visibly worn from the revised articul/eze femoral head.There was wear of the revised marathon poly liner.The femoral stem was well fixed and retained.Primary tha: (b)(6) 2000.Dor: (b)(6) 2010.Case 2: 56-year-old male patient received revision of an unknown hip 10.9 years after primary tha to treat pain, synovitis, loosening of a pinnacle cup and type ii femoral osteolysis.Upon entering the joint, severe metallosis was identified.The titanium coating was visibly worn from the revised articul/eze femoral head.There was wear of the revised marathon poly liner.The femoral stem was well fixed and retained.The femoral osteolysis was repaired with bone grafting.Doi: (b)(6) 2001.Dor: (b)(6) 2012.Case 3: 47-year-old male patient received revision of an unknown hip 10 years after primary tha to treat pain, synovitis, loosening of a pinnacle cup and unk depuy femoral stem and extensive ischium and pubis osteolysis.Upon entering the joint, severe metallosis was identified as well as extensive wear and sander marks on the revised articul/eze femoral head.There was wear of the revised marathon poly liner.The stem was loose at the bone to implant interface with a trochanteric fracture, which was repaired with a competitor cable and a depuy solution stem.The osteolysis was repaired with bone grafting.Doi: (b)(6) 2002; dor: (b)(6) 2011.

• Brand Name: UNK HIP ACETABULAR CUP PINNACLE
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18816173
• MDR Text Key: 336741745
• Report Number: 1818910-2024-04841
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETAB CUP PINN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR LINER POLY.; UNK HIP FEMORAL HEAD METAL ARTICUL/EZE.; UNKNOWN HIP FEMORAL STEM.
• Patient Outcome(s): Required Intervention