MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CPCS COCR PRIM HO 12/14 SZ 5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 71312375

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

Patient Problem Hip Fracture (2349)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a right tha had been performed on (b)(6) 2010, the patient experienced a peri-prosthetic fracture near the femoral stem area.A revision surgery was performed on (b)(6) 2020 to treat this adverse event.During this procedure, the femoral stem was explanted.The patient's health status is unknown.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

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 root cause and/or patient outcome beyond that which was reported could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should clinical documentation become available in the future, a thorough medical assessment may be rendered at that 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 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 reveal 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.

• Brand Name: CPCS COCR PRIM HO 12/14 SZ 5
• 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: 15080562
• MDR Text Key: 296369255
• Report Number: 1020279-2022-03409
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010462183
• UDI-Public: 03596010462183
• 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: 08/24/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2018
• Device Model Number: 71312375
• Device Catalogue Number: 71312375
• Device Lot Number: 08GM06632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 08/03/2022
• Supplement Dates FDA Received: 08/24/2022
• Date Device Manufactured: 07/31/2008
• 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: PN: 71302800 / LOT: 10AT38952.; PN: 75008541 / LOT: UNKNOWN.; PN: 75008721 / LOT: UNKNOWN.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male