MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM INTL BIPOLAR 46OD 28ID; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number	71324046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	10/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that the patient was hospitalized on (b)(6) 2020 for a femoral neck fracture and underwent artificial femoral head replacement using this hemi hip prosthesis component (primary surgery).Postoperatively, on (b)(6) 2020, the patient developed symptoms of infection such as wound redness and swelling with fluid exudation.Treatment: immediate debridement, local iodophor and saline irrigation were given, and the above symptoms gradually improved and disappeared.
Additional Manufacturer Narrative
Investigation results: it was reported that the patient required a surgical debridement approximately 2 weeks post-primary due to symptoms of infection accompanied by wound redness and swelling with fluid exudate.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 the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.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 review of the complaint history for the listed part revealed no prior complaints for the listed failure mode.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.A clinical evaluation noted that immediate debridement was performed with local iodophor and saline irrigation after which the "above symptoms gradually improved and disappeared/infection¿.Per correspondence, the requested clinical documentation was not available for inclusion in the medical investigation; therefore, the root cause of the suspected post-op infection could not be concluded.The patient impact beyond the reported symptoms and surgical debridement could not be determined, although the patient¿s current health status was reportedly ¿normal¿.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.No further investigation is warranted for this complaint; however smith and nephew 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 INTL BIPOLAR 46OD 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
• MDR Report Key: 11123104
• Report Number: 1020279-2021-00109
• Device Sequence Number: 642506
• Product Code: KWY
• UDI-Device Identifier: 03596010494375
• UDI-Public: 03596010494375
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K023743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2021

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: 71324046
• Device Catalogue Number: 71324048
• Device Lot Number: 20BM04037
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 03/07/2021
• 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: 71302800, LOT 20BM04037; 71324048, LOT 18KW02923; 75100467, LOT B1920344