MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX62OD METAL ACETABULAR LINER

Model Number 1218-87-362

Device Problems Degraded (1153); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559)

Event Date 07/20/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4). Initial reporter occupation: lawyer. (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.

Event Description

Pinnacle metal on metal claim letter received. Claim letter alleges pain, discomfort, difficulty walking and elevated metal ions. Mri suggested bilateral foreign body reaction with osteolysis and pseudotumor formation. Patient also suffered the following injuries but are not limited to metallosis, permanent tissue, muscle loss, limited adl and work, medical expenses, psychological and emotional injuries. Patient is seeking compensation for all the damages that have cause him. This is also serve as formal notice of claim and written demand. Doi: (b)(6) 2006; dor: unknown; right hip.

• Brand Name: PINNACLE MTL INS NEUT36IDX62OD
• Type of Device: METAL ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 12418132
• MDR Text Key: 270837808
• Report Number: 1818910-2021-19262
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/31/2011
• Device Model Number: 1218-87-362
• Device Catalogue Number: 121887362
• Device Lot Number: 2048439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/02/2021 Patient Sequence Number: 1