MAUDE Adverse Event Report: FINSBURY ORTHOPAEDICS LIMITED UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Corroded (1131); Degraded (1153); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)

Event Date 02/01/2019

Event Type  Injury  

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.

Event Description

Email notification from stryker received. It was reported that the patient had undergone a revision surgery due to disassociation of the head and the stem, trunnion failure, tissue staining and metallois and modular lfit head showed severe wear of the bearing surface as well as extensive erosion and fretting corrosion in the taper and trunnion fracture. Doi: unknown dor: (b)(6) 2019 unknown hip.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): FINSBURY ORTHOPAEDICS LIMITED; 13 mole business park, randall; leatherhead, surrey KT22 7BA; UK KT22 7BA
• Manufacturer (Section G): FINSBURY ORTHOPAEDICS LIMITED; 13 mole business park; randalls road; leatherhead, surrey KT22 7BA; UK KT22 7BA
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10283561
• MDR Text Key: 199102166
• Report Number: 1818910-2020-16052
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/06/2020
• 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

Patient Treatment Data

Date Received: 07/16/2020 Patient Sequence Number: 1

Treatment

UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP FEMORAL STEM