MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 3 HOLE ACET SHELL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Model Number	71335554
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	09/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
Us legal- bilateral patient.It was reported that after the patient underwent a first revision surgery of the left hip due to trunnionosis and metallosis on (b)(6) 2019, the patient kept suffering from complications related to prosthetic joint infection.The patient had issues with postop wound healing and developed infections, requiring surgical debridement twice, as well as recurrent aspirations.On (b)(6) 2019, the patient had a second revision surgery, where the acetabular component was replaced with antibiotic spacers.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the ¿chronic type infection-bone destructive process¿ noted intraoperatively is consistent with the pathological findings of the bacterial infections staph epi and klebsiella pneumoniae.However, both infections are highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.The infected right hip cannot be ruled out as a contributing factor to left hip infection.As well it should be noted the revision report noted that the ¿60 mm smith and nephew trial¿ was implanted.It cannot be confirmed if this was a mis-report in the document and it is referring to an implant component or if the ¿trial¿ was actually used as a stage of the revision procedure.Conclusions of using the trial as an implant cannot be concluded.The patient impact beyond the revision and expected transient post-op convalescence period cannot be determined, although it is noted the patient continued to be treated for ongoing infection post revision and had a 3rd revision.A review of the manufacturing records 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 total hip systems revealed that periprosthetic infection has been identified as a potential complication.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.Possible causes could include but are not limited to contamination, 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: R3 3 HOLE ACET SHELL 54MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• 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: 13416575
• Report Number: 1020279-2022-00410
• Device Sequence Number: 4690181
• Product Code: MBL
• UDI-Device Identifier: 03596010598257
• UDI-Public: 03596010598257
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2026
• Device Model Number: 71335554
• Device Catalogue Number: 71335554
• Device Lot Number: 16FM09620
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2016
• 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 Age: 41 YR
• Patient Sex: Male