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

Catalog Number UNK HIP HEAD METAL

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Osteolysis (2377); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/26/2019

Event Type  Injury  

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.

Event Description

Medical records received.After review of medical records patient was revised to addressed painful left hip arthroplasty, osteolysis secondary to metallosis.Patient alleged some episodes of instability, stiffness, popping and xrays demonstrated acetabular component a significant ostial lysis in zone 1 and 2, al fibrous tissue and debris were removed.Cup was approximately 50 degrees of abduction and 20 degrees of anteversion, the interface between the bone and cup was broken then the cup was removed.Femoral component was found to be grossly loose and easily removed by hand.After removing it significant proximal metaphyseal bone loss was appreciated in the femur.Doi: (b)(6) 2008 ; dor: (b)(6) 2019 ; left hip.

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.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

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.Device history lot: previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 clinical symptoms code: appropriate term/code not available (e2402) used to capture blood heavy metal increased.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Litigation record stated that patient was implanted with asr but previous medical record stated that not an asr was implanted.Patient had elevated metal ion, loss of mobility, suffering economic loss, and emotional distress.

• 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
• MDR Report Key: 12204000
• MDR Text Key: 262691182
• Report Number: 1818910-2021-15626
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/29/2021

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 HEAD METAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 08/12/2021; 09/10/2021; 10/08/2021
• Supplement Dates FDA Received: 08/13/2021; 10/05/2021; 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 40/60 PRESS FIT ACETABULUM; CORAIL 13 PRESS-FIT; UNK HIP ACETABULAR LINER METAL; UNK HIP FEMORAL HEAD METAL; 40/60 PRESS FIT ACETABULUM; CORAIL 13 PRESS-FIT; UNK HIP ACETABULAR LINER METAL; UNK HIP FEMORAL HEAD METAL
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 110