MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP FEMORAL SLEEVE ASR; HIP FEMORAL AUGMENT

Catalog Number UNK HIP FEMORAL SLEEVE ASR

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Rash (2033); Weakness (2145); Anxiety (2328); Deformity/ Disfigurement (2360); Depression (2361); Test Result (2695); No Code Available (3191); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

(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.Investigation summary.No device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Asr xl litigation records received.Plaintiff alleges pain, rashes, memory loss, abnormal chromium level, metal poisoning, weakness, metallosis, metal debris, fear, anxiety, depression and disfigurement.Doi: (b)(6) 2006.Dor: none reported.Right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative:.

Event Description

After review of medical record, patient was revised to address large adverse local tissue reaction, increasing pain and swelling.Revision notes stated that synovial fluid was removed which was reddish black color.There was a bit of corrosion around the trunnion.There was metallosis in the acetabulum.

Event Description

Additional information received.Records alleged infection prior to revision.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed andthe investigation will be re-opened as necessary.Device history lot: a device history record (mre) review, was not possible because the required lot code was not provided.H10 additional narrative: added: b5 and h6 (clinical code).H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the infections (e19).Corrected: a1, d1, d2a, d4 (catalog) and d10.

• Brand Name: UNK HIP FEMORAL SLEEVE ASR
• Type of Device: HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10080054
• MDR Text Key: 191736864
• Report Number: 1818910-2020-12440
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL SLEEVE ASR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR CUP ASR.; UNK HIP FEMORAL HEAD METAL ASR.; UNKNOWN HIP ACETABULAR CUP.; UNKNOWN HIP FEMORAL AUGMENT.; UNKNOWN HIP FEMORAL HEAD.; UNKNOWN HIP FEMORAL STEM.; UNKNOWN HIP FEMORAL STEM.; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL AUGMENT; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR