MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS COCR PRIM HO 12/14 SZ 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71312373

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hip Fracture (2349)

Event Date 11/04/2020

Event Type  Injury  

Event Description

It was reported that, after a right tha had been performed on (b)(6) 2009, the patient experienced a peri-prosthetic fracture associated to the stem prosthesis.A revision surgery was performed on (b)(6) 2020 to treat this adverse event.During this procedure, the cpcs cocr prim ho 12/14 sz 3 was explanted.The patient's health status is not known.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

Section h10: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, 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 revealed similar events for the listed device over the previous 12 months, this failure mode will be monitored for future complaints for any necessary corrective actions.Although, the batch number provided (801303) is not valid within the system, a complaint history review was performed based on the historical data and did not reveal similar events.A review of the instructions for use documents for total hip systems revealed in the warnings and precautions/preoperative section, that the patient should be warned of surgical risks, and made aware of possible adverse effects.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 potential causes that could contribute to the reported event include excessive forces applied to implant and surgical technique.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.Internal complaint reference number: (b)(4), section d4 was corrected.

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, 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 previous 12 months did not reveal similar events for the listed device.Although, the batch number provided is not valid within the system, a complaint history review was performed based on the historical data and did not reveal similar events.A review of the instructions for use documents for total hip systems revealed in the warnings and precautions/preoperative section, that the patient should be warned of surgical risks, and made aware of possible adverse effects.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 potential causes that could contribute to the reported event include excessive forces applied to implant and surgical technique.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: (b)(4).

• Brand Name: CPCS COCR PRIM HO 12/14 SZ 3
• 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: 15089980
• MDR Text Key: 296459582
• Report Number: 1020279-2022-03430
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010462169
• UDI-Public: 03596010462169
• 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,Followup
• Report Date: 10/18/2022

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: 71312373
• Device Catalogue Number: 71312373
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2022
• 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 +0, LOT#:807383; CPCS DIST CENT SZ 12MM, LOT#:80518; POLARCUP LINER 49/28, LOT#:808453; POLARCUP SHELL HA COATED 49 NON CEM, LOT#:711838
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female