MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM HD 10/12 26MM -5 EXT; PRSTHSS,HP,SMCNSTRND,MTLCRMCPLYMR,CMNTDNPRS,UNCMNTD

Catalog Number	71341909
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to dislocation and pain.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical analysis indicates that it was reported that a revision surgery was performed due to dislocation and pain approximately 10 months post implantation.Additionally, there are no patient medical records or radiographs to be provided for review.Therefore due to insufficient information, a clinical assessment cannot be performed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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: OXINIUM HD 10/12 26MM -5 EXT
• Common Device Name: PRSTHSS,HP,SMCNSTRND,MTLCRMCPLYMR,CMNTDNPRS,UNCMNTD
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7152220
• Report Number: 1020279-2017-01356
• Device Sequence Number: 10962955
• Product Code: LZO
• UDI-Device Identifier: 00885556112519
• UDI-Public: 00885556112519
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

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: 09/21/2025
• Device Catalogue Number: 71341909
• Device Lot Number: 15JM16904
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/25/2017
• Supplement Date Received by Manufacturer: 12/25/2017
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention