MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 44OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number	71324044
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after thr surgery had been performed on (b)(6) 2021, the tandem intl bipolar 44od 28id was found completely loose.This adverse event was solved by a explanation on (b)(6) 2021.The current health status of patient is unknown.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
The device was not returned for evaluation but the pictures were reviewed, and the ring separation and loosening of components was confirmed.The clinical/medical investigation concluded that, the undated x-ray provided confirms the disassembly of the bipolar head.However, they do not aid in the clinical investigation of the root cause of the reported polyethylene ring separation and loosening of the components.Therefore, based on insufficient information, a thorough medical assessment could not be performed at this time but the patient impact is limited to the revision procedure.Should any additional relevant clinical information be provided, this complaint would be re-assessed.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.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 risk management file and instructions for use documents 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, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.The contribution of the device to the reported event could be corroborated, since the ring separated, therefore, the device could not perform correctly anymore.Based on this investigation, the need for corrective action is not indicated.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: TANDEM INTL BIPOLAR 44OD 28ID
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• 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; austin, TX 78735 ; 5123913905
• MDR Report Key: 13023136
• Report Number: 1020279-2021-08712
• Device Sequence Number: 4769464
• Product Code: KWY
• UDI-Device Identifier: 03596010494351
• UDI-Public: 03596010494351
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71324044
• Device Catalogue Number: 71324044
• Device Lot Number: R2122644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 83 KG