MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN DEPUY PINNACLE METAL INSERT 36 MM X 52 MM PINNACLE MTL INS NEUT36IDX54OD

Catalog Number 121887354

Device Problems Corroded (1131); Material Disintegration (1177); Metal Shedding Debris (1804); 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 08/10/2016

Event Type  malfunction  

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 pseudotumor. The patient has developed elevated cobalt and chromium levels. An mri examination shows pseudotumors around both hips. Revision note reported cloudy fluid in the joint. There was some blackened pseudotumor present along the posterior capsule that extended up into the region of the abductors and trochanteric bursa. There was some corrosion on the taper of the femoral component.

Manufacturer Narrative

(b)(4).

Event Description

In addition to what previously alleged, ppf alleges metal wear. Doi: (b)(6), 2008 - dor: (b)(6), 2016 (left hip).

Manufacturer Narrative

(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. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. 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

Oct 24, 2017: litigation received. Litigation alleges pain and elevated metal ion levels in the blood. Revision reported metallosis and pseudotumor, described as blackened pseudotumor present along the posterior capsule that extend up into the region of the abductors and trochanteric bursa and corrosion on the taper of the femoral component. This complaint was updated on oct 31, 2017.

• Brand Name: UNKNOWN DEPUY PINNACLE METAL INSERT 36 MM X 52 MM
• Type of Device: PINNACLE MTL INS NEUT36IDX54OD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 7046104
• MDR Text Key: 104203368
• Report Number: 1818910-2017-29438
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Attorney
• 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?: No

Device Operator

• Device Catalogue Number: 121887354
• Device Lot Number: 2436899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/20/2017 Patient Sequence Number: 1