MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X MM56; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71332756
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a left da thr surgery that had been performed on (b)(6) 2024, the patient experienced infection.This adverse event was solved by a revision surgery on (b)(6) 2024, in which one (1) r3 0 deg xlpe acet lnr 36mm x mm56 and one (1) oxinium fem hd 12/14 36 mm m/+4 were changed.The patient reportedly complied with all post-operative instructions and its current health status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The photograph was reviewed, however it did not provide any insight relative to the failure mode or the root cause of the alleged failure.The clinical/medical investigation stated that, as of the date of this investigation, the requested supporting clinical documentation has not been provided.Therefore the clinical root cause of the infection and subsequent revision cannot be confirmed.The patient impact is the reported revision.A review of the production orders 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 shell and collar did not reveal similar events for the listed devices.A review of complaint history revealed a similar event for the liner and hole cover over the previous 12 months, but no similar events for their batches based on the historical data.A review of complaint history revealed similar events for the femoral head and screw over the previous 12 months, but no similar events for their batches 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 total hip systems revealed that infection, both early, post-operative superficial and early, post-operative deep wound infection and late periprosthetic infection has been identified as a potential complications associated with total hip arthroplasty surgery, primary or revision.A review of the risk management files 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 these products and event.A review of the sterilization records revealed the batches were sterilized within normal parameters.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include loss of sterility during procedure, post-operative healing issue, injury, patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should the devices 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: R3 0 DEG XLPE ACET LNR 36MM X MM56
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 20031017
• Report Number: 1020279-2024-01636
• Device Sequence Number: 6536899
• Product Code: JDI
• UDI-Device Identifier: 03596010598004
• UDI-Public: 3596010598004
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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 Catalogue Number: 71332756
• Device Lot Number: 23JL00014
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71332525 / LOT: 23MM09607.; PN: 71335556 / LOT: 23LW00039.; PN: 71336500 / LOT: 23LM04526.; PN: 71343604 / LOT: 24BM06376.; PN: 75018403 / LOT: C2320073.
• Patient Age: 70 YR
• Patient Sex: Male