MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0 DEG XLPE ACET LNR 36MM X 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71332754
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, after thr surgery had been performed on (b)(6) 2019, the patient experienced an infection.This adverse event led to a revision surgery, performed on (b)(6) 2019, in which a oxonium fem hd 12/14 36 mm -3 and a r3 0 deg xlpe acet lnr 36 mm x 54 mm were replaced and debridement was conducted.Additionally, the patient received antibiotic therapy to control the infection.The current health status of patient is unknown.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per case details, the patient experienced an infection requiring debridement, antibiotics and a revision less than 2 months after a thr.The patient current health status is unknown.The infection was treated with antibiotics.Reportedly the root cause of the revision was infection, however the source of the infection remains unknown.No further clinically relevant information was provided for evaluation.Without clinically relevant information for evaluation, the root cause of the reported events cannot be definitively concluded.Further patient impact beyond the reported revision, debridement, infection, and antibiotics, could not be assessed.No further medical assessment could be rendered at this time.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 did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.A review of the sterilization records revealed the batch was sterilized within normal parameters.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.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.
Event or Problem Description
It was reported that, after a tha surgery performed on (b)(6) 2019, due to the developed of periprosthetic joint infection of streptococcus agalactiae 2+, a revision surgery was performed on (b)(6) 2019 for an irrigation debridement and the extraction of the oxinium femoral head 12/14 taper 36 mm -3 and the r3 0 degree xlpe acetabular liner 36mm id x od 54mm.Additionally, the patient received antibiotic therapy to control the infection.This adverse event was resolved and patient is recovered, patient did not have any problem walking after the revision.
Additional Manufacturer Narrative
Internal reference number: (b)(4).Internal reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, reportedly the root cause of the head and liner revision was the periprosthetic joint (streptococcus agalactiae) infection; however, the source of the infection could not be definitively concluded.Patient impact beyond the reported irrigation/debridement, infection, antibiotics, revision, and study discontinuation could not be assessed.No further medical assessment could be rendered at this time.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 risk management file and instructions for use documents 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 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 0 DEG XLPE ACET LNR 36MM X 54MM
• 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; austin, TX 78735 ; 5123913905
• MDR Report Key: 12530550
• Report Number: 1020279-2021-07159
• Device Sequence Number: 19704909
• Product Code: JDI
• UDI-Device Identifier: 03596010597991
• UDI-Public: 03596010597991
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/08/2022

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 Model Number: 71332754
• Device Catalogue Number: 71332754
• Device Lot Number: 18BM21223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 11/03/2021; 11/03/2021; 03/04/2022
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 11/04/2021; 11/19/2021; 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2018
• 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: Required Intervention
• Patient Sex: Male
• Patient Weight: 68 KG