MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 36MM X 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71335756
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after thr on (b)(6) 2009 a revision surgery with an irrigation and debridement has been performed on (b)(6) 2021 due to a suspected infection.Current health status of the patient is unknown.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, devices analysis could not be performed.The clinical/medical investigation concluded that, per complaint details, a revision with irrigation and debridement was performed approximately 12 years post total hip arthroplasty due to ¿suspected infections¿.It was communicated that the requested clinical documentation and current patient status are not available.Although late onset infection post-prosthetic implantation (such as the reported occurrence at approximately 12 years) is rare, the occurrence usually is a result from hematogenous spread (secondary bacteremia due to infection from another site).In the absence of the requested medical documentation, clinical factors (and/or source of the infection) which could have contributed to the reported event could not be definitively concluded and a causal relationship could not be confirmed.The patient impact beyond the reported suspected (periprosthetic) infections and revision could not be determined.No further medical assessment can be rendered at this time.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 numbers over the past 30 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.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 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.Based on the clinical/medical evaluation conclusions, sterilization reviews were not performed.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include 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.
Additional Manufacturer Narrative
H6: g code has been updated.

• Brand Name: R3 20 DEG XLPE ACET LNR 36MM X 56MM
• 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: 12295401
• Report Number: 1020279-2021-06236
• Device Sequence Number: 11683113
• Product Code: JDI
• UDI-Device Identifier: 03596010598356
• UDI-Public: 03596010598356
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2023

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 Expiration Date: 12/30/2018
• Device Model Number: 71335756
• Device Catalogue Number: 71335756
• Device Lot Number: 08MM04774
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2021
• Supplement Date Received by Manufacturer: 06/28/2023; 06/28/2023
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 06/29/2023; 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown