MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR FEM HD GT 28OD +0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	71302800
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that left hip dislocation occurred due to dislodgement of the femoral head from the dual mobility liner.
Additional Manufacturer Narrative
Additional information: d11: the device, used in treatment was not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and the contraindicated off-label, concomitant use of competitor components with the smith and nephew stem cannot be ruled out as the contributing factor to the reported dislocation, which led to a 2nd revision.Without complete supporting medical records, imaging, and/or the analysis of the explanted components, it is not possible to determine whether there was proper positioning of the implant, or whether the patient sustained any traumatic injuries which may have been a contributing factor leading to the reported dislocation and revision.Therefore, it cannot be concluded that the revision was due to a mal-performance of the implant.The patient impact beyond the reported dislocation and subsequent (2nd) revision and post-operative healing and rehab cannot be determined.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 device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.Possible causes could include but not limited to traumatic injury, patient anatomy or abnormal loading of limb.A review of the risk management file and instructions for use document for this failure mode was conducted.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.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: COCR FEM HD GT 28OD +0
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8725674
• Report Number: 1020279-2019-02420
• Device Sequence Number: 1787859
• Product Code: LPH
• UDI-Device Identifier: 03596010194114
• UDI-Public: 03596010194114
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

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: 09/24/2021
• Device Model Number: 71302800
• Device Catalogue Number: 71302800
• Device Lot Number: 11JM14185
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 06/23/2019
• Supplement Report FDA Received Date: 05/20/2020
• 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: PART NUMBER 74122154/ LOT NUMBER 10DW26936
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention