MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM UNIPOLAR 50MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL

Model Number	126650
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Fluid Discharge (2686)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that after a left hip hemiarthroplasty performed on (b)(6) 2020, patient's primary wound failed to heal, with ongoing discharge from wound.Patient had revision washout and head exchange for infection on (b)(6) 2020.Implants are not available since they were sent for pathology testing.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that after a left hip hemiarthroplasty performed on 10/18/2020, patient's primary wound failed to heal, with ongoing discharge from wound.Patient had revision washout and head exchange for infection on 11/23/2020.Implants are not available since they were sent for pathology testing.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of manufacturing records did not reveal any deviation from the standard manufacturing processes.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.The device was sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.No medical documents were received for investigation.Therefore, no further clinical/medical; assessment is warranted at this time.Infection, a potential complication associated with any surgery, can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.With no patient medical records provided, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: TANDEM UNIPOLAR 50MM
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL BALL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11010948
• Report Number: 1020279-2020-07446
• Device Sequence Number: 3594210
• Product Code: LZY
• UDI-Device Identifier: 03596010079794
• UDI-Public: 03596010079794
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K896580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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: 126650
• Device Catalogue Number: 126650
• Device Lot Number: 18LM02724
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CPCS COCR PRIM SO 12/14 SZ 3; CPCS DIST CENT SZ 12MM; CPCS COCR PRIM SO 12/14 SZ 3; CPCS DIST CENT SZ 12MM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR