MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER METAL PINNACLE METAL ACETABULAR LINER

Catalog Number UNK HIP ACETABULAR LINER METAL

Device Problem Naturally Worn (2988)

Patient Problems Adhesion(s) (1695); Fatigue (1849); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Vertigo (2134); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Numbness (2415); Paresthesia (4421); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/25/2020

Event Type  Injury  

Event Description

Pinnacle litigation record received. Patient alleges pain, elevated metal ion, fatigue, tumor that caused by metallosis due to the initial implant of the metal-on-metal pinnacle device, hemarthrosis, numbness and discomfort, fluid accumulation, bleeding into the hip joint, and swelling. Patient developed a football-sized pseudotumor and related necrosis, caused by metallosis due to the initial implant of the metal-on-metal pinnacle device causing him emotional distress. Plaintiff sustained and continues to suffer damages, including, but not limited to suffering, severe and possibly permanent injuries, disability, disfigurement, economic damages (including medical and hospital expenses) monitoring, rehabilitative and pharmaceutical costs, and lost wages and loss of future earnings capacity, inability to walk without a cane, bone loss, parasthesia in right leg, mark distention in right hip, debris, kidney cancer, thyroid issues, bell's palsy, and vertigo. Doi: (b)(6) 2005 ; dor: (b)(6) 2020 ; (right hip).

Manufacturer Narrative

Product complaint # (b)(4). Initial reporter occupation: lawyer. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK HIP ACETABULAR LINER METAL PINNACLE
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13306500
• MDR Text Key: 284111604
• Report Number: 1818910-2022-01215
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK HIP ACETABULAR LINER METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 01/20/2022 Patient Sequence Number: 1

Treatment

UNK HIP ACETABULAR CUP PINNACLE; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL; UNKNOWN HIP FEMORAL STEM