MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 NEUT 44IDX62OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 122144462

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Pain (1994); Scarring (2061); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 08/29/2016

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On jun 27, 2017: legal medical records received.Pfs alleges pain, lack of mobility and leg discrepancy that resulted to rotoscoliosis, and lower back pain.After review of the medical records for mdr reportability, it was stated that the patient was revised to address trunnionosis with metal debris.Patient was noted to have significantly elevate metal ions.Revision note stated that there was a significant scarring between iliotibial band and vastus lateralis, fluid from the hip, chronic granulomatous tissue noticed in the pericapsular tissue.It was also stated that there was a metal wear and damage to the superior half of the femoral taper consistent with galvanic and crevice corrosion and damage to the taper on the femoral head.Clinic notes indicate some edema around the left hip.There are no lab values provided for the reported elevated metal ions.Review of medical records for mdr reportability determined that no indication of polyethylene liner bearing wear was reported.Additionally, as no report was made for pseudotumor, metallosis, or alval within records, only the non-specific chronic granulomatous tissue, the adverse tissue reaction harm is not supported.Both of these harms have been removed from the complaint.Ppf alleges metallosis and loosening of stem.Added law firm and revision hospital.Doi: (b)(6) 2011.Dor: (b)(6) 2016.(left hip).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ALTRX +4 NEUT 44IDX62OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9139633
• MDR Text Key: 167127674
• Report Number: 1818910-2019-106942
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016663
• UDI-Public: 10603295016663
• Combination Product (y/n): N
• PMA/PMN Number: K062148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Catalogue Number: 122144462
• Device Lot Number: 114819
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 54