MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS COCR PRIM HO 12/14 SZ 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71312372
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to poly wear & stem loosening.X-rays and notes not available.Surgeon does not blame device.
Additional Manufacturer Narrative
The associated cobalt chrome femoral head and cpcs femoral stem were not returned for evaluation.Therefore visual inspection and dimensional check could not be performed.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.However, device details were provided.Thus, a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed parts revealed no prior complaints for the listed batch with the same failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical analysis noted that no clinical documents were provided.Therefore, no thorough clinical assessment of the reported issue can be rendered at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.If the product associated with this event is returned at a future date, the evaluation will be reopened for investigation.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: CPCS COCR PRIM HO 12/14 SZ 2
• 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: 8051809
• Report Number: 1020279-2018-02390
• Device Sequence Number: 16564882
• Product Code: JDI
• UDI-Device Identifier: 03596010462145
• UDI-Public: 03596010462145
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K823727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2019

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: 02/13/2011
• Device Catalogue Number: 71312372
• Device Lot Number: 01AM01600
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 10/17/2018; 10/17/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 04/24/2019; 05/04/2019
• 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
• Patient Age: 72 YR