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

Catalog Number UNK HIP FEMORAL SLEEVE ASR

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

Patient Problems Fatigue (1849); Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Legal and medical records received.After review of medical records, it was reported that the patient presents with incredible pain, weakness and limitation to physical activities.It was also noted that patient suffers from metal on metal reaction.Elevated metal ions.The patient was then revised for failed right total hip.Operative notes reported that there was a very small effusion.There was a small amount of corrosion on the trunnion.The stem was secure with an approximately 15 degrees of anteversion.X-ray reviewed which do show well fixed components, mri does show obvious effusion w/o psuedotumor.Doi: (b)(6) 2008, dor: (b)(6) 2021, 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.Device history lot : the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.An mre (device history record) review will not be performed even when lot code(s) are known.

Event Description

Litigation alleges pain, discomfort, increase metal levels, permanent injuries, emotional distress, disability, disfigurement and economic damages including medical and hospital expenses for revision surgery followed by monitoring, rehabilitation and pharmaceutical costs.

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.Device history lot : the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.An mre (device history record) review will not be performed even when lot code(s) are known.

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.Device history lot : the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.An mre (device history record) review will not be performed even when lot code(s) are known.H10 additional narrative: added: b5 and h6 (patient) corrected: g1.

Event Description

Pfs alleges metallosis, alval, joints disabilities, limited physical activity, joint stiffness and swelling.

• Brand Name: UNK HIP FEMORAL SLEEVE ASR
• Type of Device: FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 12304080
• MDR Text Key: 265978896
• Report Number: 1818910-2021-17552
• Device Sequence Number: 1
• Product Code: KWA
• 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,Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2022
• 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
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR; UNK HIP FEMORAL STEM SUMMIT
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 71 KG