MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE MTL INS NEUT36IDX56OD; HIP ACETABULAR LINERS

Catalog Number 121887356

Device Problems Naturally Worn (2988); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Local Reaction (2035); Swelling (2091); Tissue Damage (2104); Injury (2348); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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

Claim letter received.Claim letter alleges pain in the groin, stiffness, cobalt and chrome metal ion poisoning, bone tissue damage, and the growth of a pseudotumor at the site of the implant, swelling, limited mobility, osteolytic lesion, osteolysis, among other problems.Doi: 2004; dor: (b)(6) 2017; left hip.

Manufacturer Narrative

Additional narrative: product complaint #
=
> pc-(b)(4).Investigation summary
=
> no device associated with this report was received for examination.Was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

In addition to what was previously reported, litigation also alleges disfigurement, mental anguish, suffering, and clicking sound.Doi: 2004; dor: (b)(6) 2017; left hip.

Event Description

In addition to what previously alleged, ppf alleges metal wear before first revision.Added date of implant, product experience code.Corrected patient identifier.Doi: (b)(6) 2003 - dor: (b)(6) 2017 (left hip).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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 caused or contributed to the potential event described in this report.Udi: (b)(4).

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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINNACLE MTL INS NEUT36IDX56OD
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7188934
• MDR Text Key: 97310713
• Report Number: 1818910-2018-51111
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K073504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121887356
• Device Lot Number: 1069475
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR