MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HEAD 32 + 0; PROST, HIP, SEMI-CONSTRAINED, UNCMNTD, MET/POLY, POROUS

Model Number 71303200

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

Patient Problem Unspecified Infection (1930)

Event Date 12/07/2018

Event Type  Injury  

Event Description

It was reported that, after a right thr index surgery performed on (b)(6) 2018 to address osteoarthritis symptoms, the patient sustained an unspecified infection that made necessary a revision surgery on (b)(6) 2018.During this procedure, the modular head and the acetabular liner were explanted and replaced with a smith and nephew bearing combination.This information was provided by the national joint registry of the united kingdom, as part of a retrospective data collection of patients who underwent a primary thr surgery with a hip prosthesis construct that included a polarstem stem with an r3 acetabular cup and that required a revision surgery due to specific reasons.As such, no further information will be available.

Manufacturer Narrative

Internal reference number: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of the national joint registry of england, wales, northern ireland and the isle of man (njrew) from united kingdom that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

• Brand Name: COCR 12/14 FEM HEAD 32 + 0
• Type of Device: PROST, HIP, SEMI-CONSTRAINED, UNCMNTD, MET/POLY, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16038083
• MDR Text Key: 306063369
• Report Number: 1020279-2022-05012
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K963509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71303200
• Device Catalogue Number: 71303200
• Device Lot Number: 18AT97673
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2022
• Date Device Manufactured: 01/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 71331952 / LOT 18HM23446; 71337652 / LOT 18HM08371; 75018402 / LOT B1812466
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female