MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OXINIUM FEM HD 12/14 36 MM +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71343600
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on the patient due to dislocation.No additional details of the revision surgery reported.Three explants reported.No delay or additional injuries reported.A back up device was available.
Event or Problem Description
It was reported that a revision surgery was performed on the patient due to dislocation.No additional details of the revision surgery reported.Five explants reported.No delay or additional injuries reported.A back up device was available.The femoral head has been identified as the primary part for revision.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and the pre-revision x-ray confirms the left hip fracture and a steep angle of implantation.Based on the surgeon statement the root cause of the dislocation was reportedly due to under sizing and not the fault of the smith and nephew device though the angle of the shell implantation cannot be ruled out.Per report the current status of the patient is good and the patient is walking assisted.No further clinical/medical 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.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 FEM HD 12/14 36 MM +0
• 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: 8448781
• Report Number: 1020279-2019-01164
• Device Sequence Number: 13898307
• Product Code: JDI
• UDI-Device Identifier: 03596010598363
• UDI-Public: 03596010598363
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K022958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2019

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 Catalogue Number: 71343600
• Device Lot Number: 18FM02833
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 02/28/2019; 02/28/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 03/31/2019; 06/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN 71335558/BN 18DW05389; PN 71335758/BN 18LM10935; PN 71336500/BN 18JM18823; PN 75100467/BN UNK
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention