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

Model Number 71312362

Device Problems Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hip Fracture (2349); Inadequate Osseointegration (2646)

Event Date 10/07/2015

Event Type  Injury  

Event Description

It was reported that after a right thr had been performed on (b)(6) 2009, the patient experienced loosening of the cpcs cocr prim so 12/14 sz 2 and a periprosthetic fracture on the femur.This was addressed via revision surgery on (b)(6) 2015, where the femoral stem, the femoral head and the acetabular liner were explanted.This information was provided by the national joint registry of the united kingdom, as part of a retrospective data collection of patients who underwent either a revision or re-revision surgery where a polarcup shell was part of the hip construct.As such, no further information will be available.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the data presented was obtained from the national joint registry of the united kingdom, as part of a retrospective data collection was reviewed.Per the complaint, no further information will not be provided.Consequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images and/or graphs provided in the article have been interpreted within the text; therefore, no further analysis of the images and/or graphs is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that implant loosening has been identified has been identified as an adverse event in primary and revision surgery.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as abnormal motion over time, bone degeneration, lack of ingrowth, excessive forces applied to implant, and/or traumatic injury.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Internal complaint reference number: case-2022-00112467-1 d4 lot number.

• Brand Name: CPCS COCR PRIM SO 12/14 SZ 2
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15089940
• MDR Text Key: 296462486
• Report Number: 1020279-2022-03429
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010462015
• UDI-Public: 03596010462015
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K823727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71312362
• Device Catalogue Number: 71312362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COCR 12/14 FEM HEAD 28 + 4, LOT#:610717; POLARCUP LINER 53/28, LOT#:906189; POLARCUP SHELL HA COATED 53 NON CEM, LOT#:810603
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male