MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT28IDX50OD HIP ACETABULAR LINERS

Catalog Number 121889150

Device Problems Material Disintegration (1177); Naturally Worn (2988); Appropriate Term/Code Not Available (3191)

Patient Problems Bruise/Contusion (1754); Foreign Body Reaction (1868); Inflammation (1932); Nerve Damage (1979); Pain (1994); Pocket Erosion (2013); Loss of Range of Motion (2032); Tissue Damage (2104); Distress (2329); Discomfort (2330); Injury (2348)

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pfs and medical records received. Pfs alleges no new information. After review of medical records for mdr reportability, operative notes indicate that the patient was revised due to metallosis of left hip status post remote metal on metal total hip arthroplasty, elevated serum cobalt and chromium. Progressive pain and marked elevation of serum cobalt chromium ions were also reported in the revision operative notes. It was also noted that the wound had a relatively minor degree of metallic staining of the soft tissues, particularly around the acetabular component, however there was no substantial staining of joint fluid. Clinic visits further show that patient suffered from peri-incisional ecchymosis, discomfort, difficulty sleeping and pain post implantation.

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

Manufacturer Narrative

(b)(4).

Event Description

In addition to previous allegations, ppf alleges metal wear and elevated metal ions.

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

Pinnacle litigation records received. Litigation alleges pain, swelling, lack of mobility, damage to surrounding tissue and bone caused by inflammation, metallosis, metal toxicity, bone erosion, pseudotumors, implant failure, bursitis, nerve damage and emotional distress. (b)(6) 2005 ; (b)(6) 2017 (left hip).

• Brand Name: PINNACLE MTL INS NEUT28IDX50OD
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 46581-0988 ; 6103142063
• MDR Report Key: 7189217
• MDR Text Key: 110480358
• Report Number: 1818910-2018-51179
• 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

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/21/2017

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

• Device Catalogue Number: 121889150
• Device Lot Number: 1040907
• 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: 12/09/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• 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: 01/15/2018 Patient Sequence Number: 1