MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM L/+8; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71343608
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a closed reduction due to dislocation.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation.A clinical evaluation was conducted and the dislocation was a result of the patient¿s flexing and external rotation and not associated with an immediate malfunction of the implant but it cannot be ruled out as weakness or continued joint laxity relating to the revision one month prior.A review of complaint history on the listed parts revealed no prior complaints for the listed batches 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.Some potential probable causes of the event could include, laxity in the joint or over flexing.Please refer to the instructions for use for recommendations on proper use of the device to prevent future reoccurrence of the reported event.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 36 MM L/+8
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9101204
• Report Number: 1020279-2019-03442
• Device Sequence Number: 2656642
• Product Code: JDI
• UDI-Device Identifier: 03596010477293
• UDI-Public: 03596010477293
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K022958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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: 04/04/2025
• Device Model Number: 71343608
• Device Catalogue Number: 71343608
• Device Lot Number: 15DM03794
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 01/20/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 53 YR