MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM BIPOLAR COCR 52OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 71322052

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 05/29/2020

Event Type  Injury  

Event Description

It was reported that, after a tha surgery had been performed, the patient experienced an unspecified adverse event.A revision surgery was performed in which the tandem bipolar shell/liner was exchanged.The patient outcome is unknown.

Manufacturer Narrative

H6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, it was communicated via email that no patient medical information is available for investigation.Without the relevant documents, a thorough medical assessment is not able to be conducted.Upon receipt of medical/clinical records, the clinical task will be re-opened and assessed at that time.Therefore, no medical assessment is warranted at this 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 did not reveal additional complaints for the listed batch.A review of the instructions for use documents revealed this failure mode was previously identified.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 overuse or excessive pressure on the joint, injury, infection and/or patient condition.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.

• Brand Name: TANDEM BIPOLAR COCR 52OD 28ID
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10188200
• MDR Text Key: 196206001
• Report Number: 1020279-2020-02681
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 03596010492517
• UDI-Public: 03596010492517
• Combination Product (y/n): N
• PMA/PMN Number: K023743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71322052
• Device Catalogue Number: 71322052
• Device Lot Number: 19FM06473A
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention