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

Catalog Number	71302604
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); No Code Available (3191)
Date of Event	03/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a revision of tha.Following patient hip dislocation the surgeon tred to reduce the hip by hand and after being unsuccessful performed a revision surgery.During a revision surgery surgeon found femoral head to be dislocated.
Event or Problem Description
It was additionally communicated that there had been no trauma associated with this event and that only the femoral head and tandem bi-polar shell/liner were revised, while the stem remained in-situ.

• Brand Name: COCR 12/14 FEM HD 26 + 4
• 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: 6435030
• Report Number: 1020279-2017-00217
• Device Sequence Number: 13643125
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/14/2017

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: 07/30/2026
• Device Catalogue Number: 71302604
• Device Lot Number: 16HM00355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 04/18/2017
• Initial Report FDA Received Date: 03/27/2017
• Supplement Report FDA Received Date: 03/31/2017; 04/19/2017; 07/14/2017
• 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: PLUS SL INTEGR MIA W.TI.HA 3 3, (B)(4); TNDM BP SHL/XLPE LNR 42OD 26ID, (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention