MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR 300 SPIKED CUP SIZE 54 ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999830754

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

Patient Problems Foreign Body Reaction (1868); Pain (1994); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/29/2021

Event Type  Injury  

Event Description

Asr medical record received. After review of medical record, patient was revised due to local adverse tissue reaction secondary to metallosis. Patient had elevated metal ion levels and experienced pain. Revision notes stated that a dark tea-colored thin synovial fluid was encountered. There was small amount of trunnionosis at the base of the trunnion. The acetabular component was noted to have a step-off on the inner diameter resulting in a very sharp edge. Cup was removed with a very minimal bone loss. Bone scan of the bilateral hips done (b)(6) 2021 stated increased periprosthetic tracer uptake greatest along the proximal femoral component at the greater trochanter to lesser trochanter, there is possible hardware loosening. Mri of left hip last (b)(6) 2021 stated that there is no fracture or definite loosening seen. There maybe periprosthetic effusion noted. Laboratory result last (b)(6) 2021 for chromium was 3ng/ml and cobalt was 6. 9ng/ml. Doi: (b)(6) 2009; dor: (b)(6) 2021 (left hip).

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.

• Brand Name: ASR 300 SPIKED CUP SIZE 54
• Type of Device: ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
• 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: 13453591
• MDR Text Key: 285070450
• Report Number: 1818910-2022-02301
• 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

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/30/2013
• Device Catalogue Number: 999830754
• Device Lot Number: 2743863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2008
• 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: 02/04/2022 Patient Sequence Number: 1

Treatment

ADAPTER SLEEVES 12/14 +8; ASR UNI FEMORAL IMPL SIZE 47; SUMMIT DUOFIX TAP SZ6 HI OFF