MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS COCR PRIM HO 12/14 SZ 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71312371
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to recurrent dislocation.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical analysis indicated that no clinical information has been provided for inclusion in is investigation.According to the surgeon¿s statement, ¿he felt the acetabular component may have been implanted with insufficient ante version and that coupled with the patient's unusual gait (he is a below knee amputee on the non-operative side) he may be more prone to dislocate posteriorly.¿ however, a review of the x-ray concluded that they don¿t appear to be too ante-verted.It doesn¿t appear to have changed positions or a failure of the cup or movement.The impact to the patient beyond the revision cannot be concluded.No further clinical/medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed parts revealed no prior complaints for the listed batches.Without the actual product involved our investigation cannot proceed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.If the devices are received in the future, this complaint can be re-opened.We consider this complaint closed.

• Brand Name: CPCS COCR PRIM HO 12/14 SZ 1
• 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: 7564035
• Report Number: 1020279-2018-01039
• Device Sequence Number: 11311217
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2019

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: Lay User/Patient
• Device Catalogue Number: 71312371
• Device Lot Number: 17DM17843
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 06/03/2018
• Supplement Report FDA Received Date: 02/10/2019
• 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