MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 32IDX50OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 122132150

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 04/10/2024

Event Type  Injury  

Event Description

The patient states that she was operated for the first time in the year with pinnacle corail prosthesis, cup size 48 or 50 and an insert of 32 mm.Today the patient is intervened again for a hip revision, where it is evidenced decoupling of the insert to the cup, as if it had been released, which causes displacement of the same and the femoral head , which by friction damages the polyethylene and is in contact with the cup that is also metallic.The insert and cup are removed and replaced by a new implant from another provider.Doi: (b)(6) 2018.Doe: (b)(6) 2024.

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.

Manufacturer Narrative

Product complaint: (b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification 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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, the patient states that she was operated for the first time in the year * with pinnacle corail prosthesis, cup size 48 or 50 and an insert of 32 mm.Today * the patient is intervened again for a hip revision, where it is evidenced decoupling of the insert to the cup, as if it had been released, which causes displacement of the same and the femoral head , which by friction damages the polyethylene and is in contact with the cup that is also metallic.The insert and cup are removed and replaced by a new implant from another provider.The product was not returned to depuy synthes, however photos were provided for review.See attachment source file - reporte de novedad clinica colombia colectivo 475988.The photo investigation revealed that some anti rotational devices have been sheared off from the altrx +4 10d 32idx50od.Additionally, the rim of the liner present deformation.Based on the observed damage on the liner an the position of the femoral head in relation to the acetabular liner.A disassociation from the liner with the cup is present.Therefore, the reported condition can be confirmed.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the liner failure cannot be traced to design or manufacturing, a definite root cause cannot be established due to there being multiple factors that may influence eccentric loading.Consideration must be given to all potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.It is highly recommended to the patient to consult with their healthcare professional for further assessment.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the altrx +4 10d 32idx50od would contribute to the complained device issue.Based on the investigation findings, a potential cause is traced to component failure.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: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: ALTRX +4 10D 32IDX50OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• 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 46581-0988 ; 3035526892
• MDR Report Key: 19154746
• MDR Text Key: 340739623
• Report Number: 1818910-2024-08748
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016168
• UDI-Public: 10603295016168
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K072963
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 122132150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 05/02/2024; 05/09/2024
• Supplement Dates FDA Received: 05/07/2024; 05/09/2024
• 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: Initial
• Patient Sequence Number: 1
• Treatment: ARTICUL/EZE TR BALL 32 +1 GR; PINNACLE SECTOR II CUP 50MM
• Patient Outcome(s): Required Intervention