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

Catalog Number 71354312

Device Problem Insufficient Information (3190)

Patient Problem Fistula (1862)

Event Type  Injury  

Event Description

It was reported that a surgical intervention was performed due to a wound fistula developed several months after implantation.The stem was exchanged.

Event Description

It was reported that a revision surgery was performed due to chronic infection and metallosis.

Manufacturer Narrative

The associated complaint devices were not returned.A clinical evaluation was conducted and although the intraoperative findings may be consistent with an adverse reaction to metal debris, currently unable to rule out the primary cup orientation, acetabular fracture and subsequent stem loosening as the contributing factors for the ¿metallosis¿.The presence of infection 3 weeks post implantation of smith and nephew components does not reflect a ¿chronic infection¿.It is likely, therefore, that there was a pre- existing infection prior to the implantation of the smith and nephew prostheses; however, no lab or pathology results were provided.Without the supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the source of the reported infection and/or metallosis cannot be confirmed.The patient impact beyond the reported intra-op findings during explanation and repeated left hip debridements, antibiotic therapy and revision tha cannot be determined.No further medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This included a review of sterilization documents which indicated that the product was sterilized according to sterilization release documentation.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: REDAPT STEM
• 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: 7563973
• MDR Text Key: 109880001
• Report Number: 1020279-2018-01028
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Catalogue Number: 71354312
• Device Lot Number: 12HTM0039B
• Date Manufacturer Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71352111- 15MTM0007A/75007731 -7010957634
• Patient Outcome(s): Other; Required Intervention