MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 28MM +4; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	71342804
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/03/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that right hip dislocation occurred.Joint reduction was performed to correct the problem.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and the intraoperative findings of the reported elevated metal ion levels and altr may be consistent with findings associated with metal debris; however, the root cause of the reported symptoms noted in the legal claim cannot be concluded, and it cannot be concluded that the reported reactions/events were associated with a mal-performance of the implant.The patient¿s dislocations cannot be ruled out as a contributing factor for the subsequent right hip dislocation and peripheral neuropathy.The patient impact beyond the revision and the expected post-operative healing/pain cannot be determined.No further clinical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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.

• Brand Name: OXINIUM FEM HD 12/14 28MM +4
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8519419
• Report Number: 1020279-2019-01586
• Device Sequence Number: 1516378
• Product Code: KWP
• UDI-Device Identifier: 03596010474162
• UDI-Public: 03596010474162
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K021673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2023
• Device Catalogue Number: 71342804
• Device Lot Number: 13EN06545
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR