MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Fall (1848); Pain (1994); Loss of Range of Motion (2032)

Event Date 06/01/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed stoltny t, pasek j, rokicka d, wróbel m, dobrakowski m, kaminski p, domagalski r, czech s, strojek k, koczy b.Are there really specific risk factors for heterotopic ossifications? a case report of 'non-risk factor' after total hip replacement.J int med res.2022 jun;50(6):3000605221095225.Doi: 10.1177/03000605221095225.Pmid: 35726568; pmcid: pmc9218464.Objective and methods: this case report describes as a 70-year-old male patient that presented with an old hip fracture accompanied by a mild craniocerebral trauma after being beaten in july 2018.The fracture was treated with depuy pinnacle/corail total cementless hip arthroplasty followed by rehabilitation.After a fall 8 months after primary tha, the patient was diagnosed with brooker iv° heterotopic ossification in the area of the operated hip joint.Due to the persistent pain, walking difficulty, and complete loss of mobility in the operated joint, computed tomography imaging was performed, and the patient was recommended for a revision surgery in october 2019.The revision was performed 14 months after the original surgical treatment, with excision of the extraskeletal ossification, resulting in a significant improvement in the range of motion and reduction of pain.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: 52 mm pinnacle cup 35/52 mm marathon poly insert size 12 corail stem 32 mm +13 metal femoral head adverse event(s) and provided interventions associated with depuy devices: extraskeletal ossification, pain, walking difficulty, and medical device site joint range of motion decreased treated with revision radiographic.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK HIP FEMORAL HEAD METAL
• Type of Device: METAL FEMORAL HEAD
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15053663
• MDR Text Key: 296152875
• Report Number: 1818910-2022-13416
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 08/24/2022
• 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 Sequence Number: 1
• Treatment: UNK HIP ACETABULAR CUP PINNACLE; UNK HIP FEMORAL STEM CORAIL; UNKNOWN HIP ACETABULAR LINERS
• Patient Outcome(s): Required Intervention
• Patient Sex: Male