MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COCR 12/14 FEM HD 26 + 4; PROSTHESIS,HIP,SEMICONSTRAINED,METAL/POLYMER,POROUS

Catalog Number	71302604
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to dislocation that caused by patient falling down.The liner and inner head were exchanged.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of complaint history did not reveal additional complaints for the listed batches.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The medical investigation concluded that several attempts have been made to obtain clinical/medical documents to support this complaint.It has been communicated that no information would be forth coming.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.Without the actual devices involved our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: COCR 12/14 FEM HD 26 + 4
• Common Device Name: PROSTHESIS,HIP,SEMICONSTRAINED,METAL/POLYMER,POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9109316
• Report Number: 1020279-2019-03462
• Device Sequence Number: 3587368
• Product Code: LPH
• UDI-Device Identifier: 03596010194084
• UDI-Public: 03596010194084
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2019

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: 01/05/2024
• Device Catalogue Number: 71302604
• Device Lot Number: 14AM04621
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 12/01/2019
• 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: Hospitalization; Required Intervention