MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL STEM TRI-LOCK

Catalog Number UNK HIP FEMORAL STEM TRI-LOCK

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

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Dizziness (2194); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Depression (2361); Numbness (2415); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 03/28/2022

Event Type  Injury  

Event Description

Asr litigation record received.Litigation alleges severe pain, discomfort, elevated metal levels cobalt and chromium, emotional distress, permanent injuries, disability, disfigurement and economic damages.Doi: (b)(6) 2009.Dor: (b)(6) 2022.Left hip.

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: (b)(6).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.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).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Plaintiff form and medical records.After review of medical records patient was revised due to metallosis and failed right total hip arthroplasty.Operative notes indicated that there was not much ingrowth around the cup and the cup came out easily.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.The update received on 30-november-2022 did not have any additional details to be added to investigation.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.

Event Description

Pfs alleges pain, soreness and discomfort along the front right thigh region.Further alleged puffiness, swelling in the right ankle, decrease stamina, endurance, limited mobility, anxiety, fear of elevated metal ions, metallosis, dizziness, numbness/tingling along the toes and fingers, weakness, tiredness and change in gait, limited adl, emotional distress and depression.

• Brand Name: UNK HIP FEMORAL STEM TRI-LOCK
• Type of Device: HIP FEMORAL STEM
• 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: 15199138
• MDR Text Key: 297601208
• Report Number: 1818910-2022-15533
• Device Sequence Number: 1
• Product Code: LPH
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/10/2022

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 STEM TRI-LOCK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 08/16/2022; 08/19/2022; 12/09/2022
• Supplement Dates FDA Received: 08/17/2022; 08/24/2022; 12/09/2022
• 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 ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 73 KG