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

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

Patient Problem Pain (1994)

Event Date 05/10/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that after a thr, a revision surgery was performed on (b)(6) 2021 due to pain over the greater trochanter area.There is suspicion about probable deep scar entrapment iliopsoas and it band.The oxinium femoral head 36 +0 was replaced with 71343600 (20em09054).The patient was not harmed beyond the described event.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a revision was performed due to pain over the greater trochanter area with ¿suspicion about probable deep scar entrapment iliopsoas and it band¿.Reportedly, the patient was not harmed beyond the described event.Responses to the information requests have not been provided as of the date of this medical assessment.Without the requested medical documentation, the clinical root cause of the reported event could not be definitively concluded, although the reported ¿probable deep scar entrapment iliopsoas and it band¿ was suspected.The patient impact beyond the reported pain and subsequent revision could not be determined.No further medical assessment could be rendered at this time.Should additional clinically relevant documentation become available the medical investigation task may be re-evaluated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, joint tightness, material in use, patient reaction or loss of sterility.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is 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 MEMPHIS OX
• 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: 11980230
• MDR Text Key: 255596878
• Report Number: 1020279-2021-05124
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention