MAUDE Adverse Event Report: DEPUY IRELAND 9616671 STD MITCH TRH CUP SIZE 46/52; HIP ACETABULAR CUP

Catalog Number MAC99884652

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Anemia (1706); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Discomfort (2330); Joint Dislocation (2374); Ambulation Difficulties (2544); Joint Laxity (4526); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)

Event Date 09/22/2020

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

Surgeon confirmation form received.It was stated that a mitch product was implanted.Patient experienced metal debris (armd), metallosis, aseptic lymphocytic vasculitis associated lesions (alval), and trauma.Patient alleges that hip had shattered inside and that x-ray revealed that prosthesis had snapped.Doi: (b)(6) 2008 - dor: (b)(6) 2020 (left 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).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

Claim alleges pain, limited range of motion, walking difficulty, sleeping bending, shortening of the femur and subluxation.Claimant is seeking compensation for all the damages.After review of the medical records the patient was revised to address elevated metal ion, dislocation, shattered hip device and leg disengagement dissociation of the femoral neck trunnion from the femoral stem and metallosis resulting to hip pain, discomfort, limited adl, walking difficulty, limited range of motion.Operative finding reported extensive titanium staining corroded, trunnionosis and fractured trunnion, segmental bone loss above the acetabular cup.Tissue histology reported synovitis secondary to metal body debris.Lab result shows above 7ppb.Post op complication is anemia due to excessive blood lost patient required to had 1 u prbc and was admitted in the icu.Doi: (b)(6) 2008.Sept 22, 2020 affected side: left hip.

• Brand Name: STD MITCH TRH CUP SIZE 46/52
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• 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: 14944568
• MDR Text Key: 295411085
• Report Number: 1818910-2022-12482
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2011
• Device Catalogue Number: MAC99884652
• Device Lot Number: FM063866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/07/2022
• Supplement Dates Manufacturer Received: 07/11/2022; 08/16/2022
• Supplement Dates FDA Received: 07/11/2022; 08/17/2022
• 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: ACCOLADE STEM TMZF; MITCH TRH MODULAR HEAD 46 +0 NECK; UNK HIP ACETABULAR CUP MITCH; UNK HIP FEMORAL HEAD METAL
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female