MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Loss of Osseointegration (2408); Naturally Worn (2988); Unintended Movement (3026)

Patient Problems Cyst(s) (1800); Foreign Body Reaction (1868); Pain (1994); Pocket Erosion (2013); Scarring (2061); Joint Disorder (2373); Osteolysis (2377); Inadequate Osseointegration (2646); Test Result (2695); No Code Available (3191)

Event Date 12/19/2017

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

Asr medical records received. After review of medical record, the patient was revised to address failed right total hip replacement involving articular surface wear, adverse local tissue response, and periprosthetic osteolysis, aseptic loosening of the acetabular component, acetabular erosion and pseudocyst of the thigh. Revision notes reported large osteolytic cyst. The posterior aspect of the thigh appeared to be filled with murky fluid which was stained black. Scar formation was noted. Patient's hip was quite stiff. There was notching of the anterior neck of the femoral component by approximately 2-3 mm, suggesting it was impinging on the anterior aspect of his metal on metal component. There was small osteolytic lesion in zone 7. Acetabular component was grossly loose and was clearly mobile. Clinical visits reported pain, elevated metal ions, and cystic mass of 10. 5 cm. Doi: (b)(6) 2009 - dor: (b)(6) 2017, (right hip).

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 8804791
• MDR Text Key: 151508033
• Report Number: 1818910-2019-98729
• Device Sequence Number: 1
• Product Code: KWY
• 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: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• 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: 07/18/2019 Patient Sequence Number: 1