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

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 04/10/2013

Event Type  Injury  

Event Description

It was reported that a left hip revision surgery of oxinium femoral head was performed due to unclear reasons.

Manufacturer Narrative

The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that this patient had a second revision 8 days after the first revision.Per operative report, the surgeon stated that this revision was due to a ¿failed acetabulum revision surgery¿.Intraoperative findings were a copious amount of organized and unorganized hematoma was encountered in the subcutaneous space.The fascia had dehisced.It appeared that the ilium and acetabulum were reconstructed and supported with plates, cables and screws.According to the records, it is unclear as to why the acetabulum revision surgery failed.Although intraoperative findings of a copious amount of organized and unorganized hematoma and a dehisced fascia occurred after the first revision.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the root cause of the reported ¿failed acetabulum revision surgery¿ cannot be concluded but some patients may be predisposed, it may be complication of joint surgeries and is related to the procedure and not the device.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.No further clinical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of the reported event could include dehisced fascia or hematoma.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: HIP IMPLANT
• Type of Device: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9311440
• MDR Text Key: 166032291
• Report Number: 1020279-2019-03956
• 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: other
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention