MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX50OD PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887350

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Osteolysis (2377); Ambulation Difficulties (2544); Fibrosis (3167); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). Initial reporter occupation: lawyer. Follow-up is being conducted to obtain legal contact information. If/when the contact information is received, a supplemental med watch report will be submitted. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle unf and medical record received. After review of the medical records the patient was revised due to symptomatic metallosis, pseudotumor, alval, elevated metal ions, crp and sedimentation rate resulting to pain, bone necrosis of the proximal femur, large lytic lesion of the ischium, limp and leg length difference. Operative note reported pseudotumor fluid collection approx. 15 cc of red serosanguinous fluid. There is significant pseudo-capsular expansion and grade tinted stained tissue consistent with metal debris and damage. Cup looks vertical and anteverted related to spinal pelvic imbalance. Compromise of the abductors by the necrosis of the trochanter from the metallosis damage. Pathology report component had thick fibrosis and synovial lining eroded. Moderate grade for alval. Lab result for chromium and cobalt shows above 7 ppb. Doi: 2009: dor: (b)(6) 2019; left hip.

• Brand Name: PINNACLE MTL INS NEUT36IDX50OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11349533
• MDR Text Key: 232597232
• Report Number: 1818910-2021-03437
• 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: consumer,other

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 121887350
• Device Lot Number: 2812609
• 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: 04/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 02/19/2021 Patient Sequence Number: 1

Treatment

ARTICULEZE M HEAD 36MM +1.5; DEPUY SUMMIT SIZE 2; PINNACLE ACETABULAR CUP SIZE 50; PINNACLE MTL INS NEUT36IDX50OD