MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS COCR PRI HO 12/14 SZ 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71312370
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to loosening of stem with osteolysis at the femur and acetabulum, and recurrent dislocations.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that the root cause of the reported loosening and metallosis cannot be confirmed.Without complete supporting medical documents and analysis of the explanted device, a thorough investigation cannot be performed.Based solely on the revision operative report, it is not possible to determine or confirm proper positioning of the implant or whether the patient had any underlying comorbidities, which may have been a contributing factor to the reported loosening and revision.Therefore, it cannot be concluded that the revision was due to a mal-performance of the implant.No further clinical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes of this event could include surgical technique, osteolysis or a traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.

• Brand Name: CPCS COCR PRI HO 12/14 SZ 0
• 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: 8904427
• Report Number: 1020279-2019-03080
• Device Sequence Number: 1617912
• Product Code: JDI
• UDI-Device Identifier: 03596010462138
• UDI-Public: 03596010462138
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K970351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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 Model Number: 71312370
• Device Catalogue Number: 71312370
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 08/18/2019
• Supplement Report FDA Received Date: 03/31/2020
• 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