MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 32MM +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 71343200

Device Problem Device Damaged by Another Device (2915)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, after a thr had been performed, the r3 0 deg xlpe acet lnr 32mm x 50mm broke and become dislodged.This adverse event was treated with a revision surgery performed on (b)(6) 2020, in which the r3 0 deg xlpe acet lnr 32mm x 50mm and oxinium fem hd 12/14 32mm +0 were replaced.Due to revision surgery, the patient currently experiences some level of pain and decreased range of motion daily.

Manufacturer Narrative

Further review of this case indicates this is a duplicate report.The event in this report has been already reported under mdr no.(b)(4).All further communication for this event will be managed in that case, including a follow up report with the results of our investigation.We respectfully request to close the case as a duplicate and refer to the referenced case above.

• Brand Name: OXINIUM FEM HD 12/14 32MM +0
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12471534
• MDR Text Key: 271440159
• Report Number: 1020279-2021-06839
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010474209
• UDI-Public: 03596010474209
• Combination Product (y/n): N
• PMA/PMN Number: K021673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71343200
• Device Catalogue Number: 71343200
• Device Lot Number: 20HM02158
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention