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 Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/25/2021

Event Type  Injury  

Event Description

It was reported as " my mother (b)(6) is having her hip replaced (b)(6) 2021. Because she has issues with her depuy johnson & johnson hip put in (b)(6) 2008. I am her daughter (b)(6) and have poa. She is suffering from issues due to the hip. High cobalt and chromium levels in her blood stream which may have led to her memory issues, heart issue along with corrosion of bone and tissue muscle her doctor can explain better than i can, his name is dr. (b)(6) orthopedic surgeon at (b)(6). Nurse (b)(6). Telephone xxx-xxx-xxxx. (b)(6) i have provided the original information of when she originally had hip replace in 2008, dr. (b)(6). (b)(6). Long operative note - (b)(6) (m. D. ) - (b)(6) 2008 12:00 am pdt. Preoperative diagnosis: severe right hip pain. Postoperative diagnosis: severe right hip pain due to complete collapse of the right femoral head. Surgical procedure: right total hip arthroplasty using the depuy total hip system. Stem was summit size 4 high offset. Cup was 50 asr cup. Head was 45 mm femoral head, cobalt chrome. Neck was minus-1 neck. (b)(6). (mrn: xxxxxxx) ¿ printed at 10/19/21 10:38 am page 6 of 8. I would like to know what your company can do to compensate her for all we have been through, please respond as soon as possible. ".

Manufacturer Narrative

(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12746857
• MDR Text Key: 284813420
• Report Number: 1818910-2021-24334
• 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

• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK HIP FEMORAL SLEEVE ASR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2021
• 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 Treatment Data

Date Received: 11/03/2021 Patient Sequence Number: 1

Treatment

CUP WAS 50 ASR CUP; HEAD WAS 45 MM FEMORAL HEAD COBALT CHROME; NECK WAS MINUS-1 NECK; STEM WAS SUMMIT SIZE 4 HIGH OFFSET