MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX54OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Model Number 1218-87-354

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Ambulation Difficulties (2544); Test Result (2695)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No device associated with this report was received for examination.A worldwide complaint database search made on liner lot 2275341 & head lot 2377645 found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Database searches made on the stem lot 2343755 identified one (b)(4) previous complaint.Database searches made on the cup lot bh6j11000 identified one (b)(4) previous complaint.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

Event Description

It was reported that the patient have been facing inconvenience pain in the hip area, too much of joint noise and other issues.Also experiencing loud and continuous cracking noise with every movement and leading to limping.This is affecting by daily routine, hampering the patient's work and mental peace.The patient is scared and concerned with the rate of increase in metal levels in blood.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : update 21-jul-2021: the investigation was re-opened upon receipt of the device.Examination of the returned device identified areas of wear and corrosion.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : the alleged adverse symptoms, and the product code reported, are associated with the articulation between depuy metal-on-metal products.It has been determined that should additional reports be identified for related metal-on-metal complications, a device history record (dhr) review is not required, as the components have been removed from the market.Therefore, a complaint database search and/or device manufacturing review will not be performed for the reported product associated with this investigation.

• Brand Name: PINNACLE MTL INS NEUT36IDX54OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9526021
• MDR Text Key: 185396049
• Report Number: 1818910-2019-124793
• Device Sequence Number: 1
• Product Code: OVO
• Combination Product (y/n): N
• PMA/PMN Number: P090002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1218-87-354
• Device Catalogue Number: 121887354
• Device Lot Number: 2275341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR