MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN FEMORAL HEAD IMPL; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Device Problem Unstable (1667)

Patient Problem Failure of Implant (1924)

Event Date 06/18/2020

Event Type  Injury  

Event Description

It was reported that during thr procedure large patient, became unstable.The doctor thought her cup was overly anteverted.So he removed the 56mm 3-hole shell, 36 20 degree liner and 36 +4 ox head.He replaced them with a 64 redapt modular shell, 6.5x35 screw, 6.5x30 locking screw, 44 20 degree liner, 44 ox head, +8 taper.Patient was stable on the table.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation, therefore the failure could not be confirmed.The clinical/medical team concluded, this complaint from the united states reports a revision of an unstable hip secondary to being ¿overly anteverted¿ the surgeon replaced the 56mm 3-hole shell, 36 20 degree liner and 36 +4 ox head.The impact to the patient cannot be determined with the limited information provided.Smith and nephew has not received adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKNOWN FEMORAL HEAD IMPL
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10268928
• MDR Text Key: 198680658
• Report Number: 1020279-2020-03177
• Device Sequence Number: 1
• Product Code: JDH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention