MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN DEPUY PINNACLE LINER 36MM X 52MM; PINNACLE MTL INS NEUT36IDX52OD

Catalog Number 121887352

Device Problems Corroded (1131); Material Disintegration (1177); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Muscle Spasm(s) (1966); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671)

Event Date 07/13/2016

Event Type  Injury  

Manufacturer Narrative

Udi: unavailable.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.See section d for any product information received.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.

Event Description

Litigation received.Litigation alleges pain and elevated metal ions.Revision noted metallosis with pseudotumor and corrosion on the trunnion of the taper and of the metal liner.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.Depuy considers the investigation closed at this time.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.

Event Description

In addition to what was previously litigated, patient also alleges right groin discomfort, developed numbness in her legs, spasms, decreased range of motion.Patient continues to experience muscle tightness, pain and intermittent muscle spasm.After review of medical records for mdr reportability it was reported that the patient was revised to address metallosis and pseudotumors.Patient had developed pain and has elevated cobalt and chromium levels.Mri examination shows evidence of pseudotumors around her hips.Revision note reported a cloudy fluid in the joint, this was the fluid that is typically seen in metallosis.There was a lot of pseudotumor posteriorly.There was a lot of corrosion on the trunnion of the taper and in the metal liner.

Manufacturer Narrative

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.

Manufacturer Narrative

(b)(4).

Event Description

In addition to what previously alleged, ppf alleges metal wear.Updated patient's identifier, patient harm, law firm in the facility name.Added lawyer in the associated contact and patient's address.

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 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).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, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN DEPUY PINNACLE LINER 36MM X 52MM
• Type of Device: PINNACLE MTL INS NEUT36IDX52OD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7046336
• MDR Text Key: 92543722
• Report Number: 1818910-2017-29426
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K003523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2011
• Device Catalogue Number: 121887352
• Device Lot Number: 2175626
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 114