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

Catalog Number UNK HIP FEMORAL HEAD METAL

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Fatigue (1849); Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Depression (2361); Ambulation Difficulties (2544); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)

Event Date 12/09/2011

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Initial reporter occupation: lawyer.Component code: (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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Pfs and medical records received ad 21 dec 2022.Pc was created to capture the event.After review of medical records patient was revised due to periprosthetic infection versus metallosis reaction.Operative notes indicated that patient had tripped over her pet animal and fell on her hip.Since then, she noticed significant pain prior to revision.Upon incision, immediately gross amounts of turbid yellow fluid extruded, not completely characteristics of pus but copious in amount.The entire area was inspected and noted to be vital and not grossly infected.After complete evacuation of fluid, the hip joint itself appeared very healthy and sterile with no gross evidence of infection.An extensive metallosis with black debris also noted.Doi: (b)(6) 2011.Dor: (b)(6) 2011.Left hip.

Event Description

In addition to what was previously alleged.Pfs alleges hip surgeon extensive metallosis with black debris in the hip, lost significant amount of muscle and tissue in the hip.Leg length discrepancy 3/4 the size of right leg, pain, weak hip, weight bearing, walking difficulty, limited rom and depression.Doi: (b)(6) 2011.Dor: (b)(6) 2011.Left hip revision 2nd complaint.

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.Update 5/22/2023 update 15 may 2023 received did not have any additional details to be added in 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.H10 additional narrative:.

• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16132303
• MDR Text Key: 307021512
• Report Number: 1818910-2023-00934
• 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
• Report Date: 01/10/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 05/22/2023
• 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: NEUTRAL LINER SIZE58MM; NEUTRAL LINER SIZE58MM; PRODIGY LG STAT SHT LT 12.0MM; SIZE 40MM; UNK HIP ACETABULAR CUP PINNACLE
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female