MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

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

Patient Problems Fall (1848); Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Distress (2329); Joint Laxity (4526); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/19/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pinnacle litigation record received.Patient alleges pain, elevated metal ion, wear, ct scan which found a pelvic mass consistent with arthroplasty related particle disease.As direct and proximate result of the failure of defective pinnacle hip system,patient sustained and continues to suffer economic damages, severe and possibly permanent injuries,suffering, and emotional distress.(b)(6) 2010.Dor: (b)(6),2021.(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.

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

Medical records received.After a review of the medical records, on (b)(6) 2022, the patient underwent a bilateral lumbar l3-l5 facet medial branch nerve block procedure due to back pain.On (b)(6) 2022, the patient underwent bilateral lumbar l2-l3 and l3-l4 medial branch radiofrequency ablation due to back pain.On (b)(6) 2018 office visit, the mri scan impression was extensive abnormal thick-walled fluid collection along the anterosuperior aspect of the prosthesis.It was consistent with reactive synovitis/alval.On (b)(6) 2021, the patient experienced significant hip stiffness.The pain was localized to the groin and buttock area and exacerbated by weight-bearing, twisting, and pivoting activities.The patient admits to falls/instability.On (b)(6) 2021, post-operative right tha patient's pain level was 4/10 in severity, and has difficulty with mobilization.On (b)(6) 2022, the patient was having pain with increased activity.On (b)(6) 2022, the patient reported pain in the lower back portion that radiates to his right leg.Rated pain as 5-6/10.It was described as dull, throbbing, and sharp in quality.On (b)(6) 2022, mr hip without contrast ( r ) impression obtained abnormal heterogeneous thick-walled collection with extensive debris extending anteromedially and superiorly along the medial aspect of the intact iliopsoas tendon.A small abnormal collection/synovitis is noted antero-inferiorly.Both collections are consistent with alval.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

After review of the medical records, patient was revised due to the following findings: severe metallosis; severe bone loss of acetabular and femoral bonce; 500cc effusion of cloudy black fluid; trunionosis of femoral component taper; fracture of the proximal femur requiring orif.Doi: (b)(6) 2010 and dor: (b)(6) 2021 (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not received for examination.Based on the visual analysis of the provided photographic evidence for, it cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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

Medical records were received and stated the following: clinic visit from (b)(6) 2021 states the patient has right knee pain that the physician associates to a torn meniscus and osteoarthritis, which would be unrelated to the total hip revision.Notes also state the hip xray review indicates no signs of loosening but pre-op xrays prior to the revision show a loose tri lock stem in varus.Notes from (b)(6) 2022 state the patient sustained a fall on his right hip and is unable to place weight on it.He c/o significant pain.Right hip xrays show the cup is in slight anteversion with a screw into the acetabulum with lateral lucencies with the appearance of a loose cup.

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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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.

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

Medical records were received: on (b)(6) 2023, the patient underwent a right hip revision, resection of proximal 3/8 femur with fragmented bone, removal of pseudotumor and insertion of cemented prostalac to address infected right hip, diffuse cellulitis, segmental bone loss proximal 3/8 femur with fragmentation, greater trochanteric deficiency with escape superior migration and fragmentation, metallosis, osteomyelitis, multifocal deep abcess, pseudotumor, and pain.Depuy cup with a metal bearing, dual-mobility bearing in place, there was a competitor restoration mod stem were removed.Competitor cement and components were implanted during this procedure.

Manufacturer Narrative

Product complaint # (b)(64.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.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14278907
• MDR Text Key: 290651622
• Report Number: 1818910-2022-08092
• Device Sequence Number: 1
• Product Code: JDI
• 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,Followup
• Report Date: 05/03/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 05/09/2022; 03/01/2023; 03/20/2023; 04/12/2023; 04/26/2023; 07/14/2023; 07/27/2023; 08/18/2023
• Supplement Dates FDA Received: 05/10/2022; 03/15/2023; 03/24/2023; 04/17/2023; 04/26/2023; 07/27/2023; 08/02/2023; 08/24/2023
• 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
• Patient Sequence Number: 1
• Treatment: UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male