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); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Anxiety (2328); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544); Limb Fracture (4518); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559)

Event Date 10/12/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.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.

Event Description

Patient was revised with removal of right asr head, taper and cup.There was no loosening reported.Doi: (b)(6) 2008.Dor: (b)(6) 2022.Affected side: right hip.

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.

Event Description

Plaintiff preliminary disclosure (ppd), plaintiff disclosure form (pdf) and asr medical record received.Ppd and pdf has no new information provided.After review of the medical records the patient was revised to address mechanical complication, pseudotumor and elevated metal ions.Operative note reported pseudotumor appearing as black tissue, the greater trochanter was bald without evidence of the gluteus medius or minimus insertion, short external rotators and capsule were repair, head was removed and there was slight evidence of trunnionosis, majority of trunnion was without damage.Femoral stem was stable.Cup was removed with minimal bone loss.The posterior wall of the acetabulum demonstrated to be thin.The hip was reduced without complication.Doi: (b)(6) 2009; dor: (b)(6) 2022; right hip.

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.

Event Description

Pfs alleges severe hip pain, elevated metal ions, pseudotumor, injuries to tendons, ligaments, tissues and bones, metallosis, walking difficulties, weakness and anxiety.In addition to what was previously reported in the medical records, clinical visit reported thigh weakness, fatigue, post-operative discovered fractured right femur.X-ray revealed well healed fracture right side.Decreased range of motion, hip pain, impaired adl.Doi: (b)(6), 2009 dor: (b)(6), 2022 affected side: right hip.

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 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.H10 additional narrative: h6 clinical codes: - unspecified tissue injury (e2015) is used to capture bone injury and soft tissue injury; - fatigue (e2312) is used to capture weakness and fatigue.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.E3 initial reporter occupation: lawyer.

• Brand Name: UNK HIP FEMORAL STEM TRI-LOCK
• Type of Device: 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 drive; warsaw IN 46582 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17069996
• MDR Text Key: 316689307
• Report Number: 1818910-2023-11637
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/06/2023

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?: Yes
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 06/08/2023; 06/23/2023; 07/24/2023
• Supplement Dates FDA Received: 06/08/2023; 06/26/2023; 07/28/2023
• 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
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR CUP ASR.; UNK HIP ACETABULAR CUP ASR.; UNK HIP FEMORAL HEAD METAL ASR.; UNK HIP FEMORAL HEAD METAL ASR.; UNK HIP FEMORAL SLEEVE ASR.; UNK HIP FEMORAL SLEEVE ASR.; UNK HIP FEMORAL SLEEVE ASR.
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 83 KG