MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 50OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number	71324050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after an hemiarthroplasty, a revision surgery was performed to exchange a tandem intl bipolar 50od 28id due to infection.The current health status of the patient is unknown.
Additional Manufacturer Narrative
Section h3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported events cannot be determined with the information provided.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for endoprostheses systems revealed that acute postoperative wound infection has been identified as an adverse effect.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the sterilization records revealed the batch was sterilized within normal parameters.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 that could contribute to the reported event include loss of sterility during procedure, patient reaction, and post-operative healing issue.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: TANDEM INTL BIPOLAR 50OD 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, TX 78735 ; 5123913905
• MDR Report Key: 15540204
• Report Number: 1020279-2022-04310
• Device Sequence Number: 7073938
• Product Code: KWY
• UDI-Device Identifier: 03596010494412
• UDI-Public: 03596010494412
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: 71324050
• Device Catalogue Number: 71324050
• Device Lot Number: P2142199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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; Hospitalization
• Patient Sex: Unknown