MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN FEM HEAD IMPL MEMPHIS; PROSTHESIS, HIP, SEMI-CONSTRAINED

Catalog Number UNKNOWN

Device Problem Device-Device Incompatibility (2919)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during a thr, surgeon implanted a 32mm diameter head in a 36mm diameter liner and the two devices are not compatible.Patient will need revision surgery to swap out the head and the liner for a compatible pair.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this case reports that the sizes of the implanted head and liner are not compatible, and a revision is required to swap out for a compatible size.Per complaint detail, the s&n sales rep was not present during the surgery.It is unknown if/when the revision is to be performed, and whether both devices will be replaced.This information has been requested, but not provided.Therefore, the patient impact beyond the need for a future revision cannot be determined.Should additional relevant documentation become available, the clinical/medical task may be re-opened.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: UNKN FEM HEAD IMPL MEMPHIS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11026877
• MDR Text Key: 222010125
• Report Number: 1020279-2020-07551
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention