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	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to the stem being loose after a fracture.
Additional Manufacturer Narrative
It was reported that the patient had a fall and sustained a peri prosthetic fracture.Then a revision surgery was performed due to the stem being loose after a fracture.The associated cpcs collarless high offset stem nor the cobalt chrome femoral head were not returned for evaluation.However picture was provided.A visual inspection of the photo could not confirm the stated failure.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A clinical evaluation noted that the provided x-ray image supports the reported periprosthetic fracture post plate and cabling.The patient impact beyond the reported loosening post plate/cabling and revision could not be determined.No further medical assessment can be rendered at this time.The reported fall cannot be ruled out as a contributing factor to the loosening and periprosthetic fracture.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• 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: 8980067
• Report Number: 1020279-2019-03322
• Device Sequence Number: 276187
• Product Code: JDI
• UDI-Device Identifier: 03596010462152
• UDI-Public: 03596010462152
• 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 Implanted Year: 2018
• 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): 12/26/2019

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 Catalogue Number: 71312372
• Device Lot Number: 17LM02321
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 12/26/2019
• 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