MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 20 DEG XLPE ACET LNR 32MM X 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71337648
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, 1 year and 8 months after an arthroscopy performed on (b)(6) 2022 in which a r3 system was implanted, the patient suffered from early wear of the polyethylene insert with clinical observation of metallosis due to friction in the subsequent metallic components generating complications and pigmentation alterations and possible infection in the tissues surrounding the treated area.The patient underwent a revision surgery.It is unknown which devices were explanted.The current state of health of the patient is unknown.
Event or Problem Description
It was reported that, 1 year and 8 months after an arthroscopy performed on (b)(6) 2022 in which a r3 system was implanted, the patient suffered from early wear of the polyethylene insert with clinical observation of metallosis due to friction in the subsequent metallic components generating complications and pigmentation alterations and possible infection in the tissues surrounding the treated area.The patient underwent a revision surgery.It is unknown which devices were explanted.Patient's health status is good.
Additional Manufacturer Narrative
B5: describe event or problem, e1: name and address, e2: health professional, e3: occupation.Section h3, h6: the reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the r3 20 degree xlpe acetabular liner 32mm id x od 48mm.Therefore, no investigation is deemed for the other devices.The clinical/medical investigation concluded that the four provided photos of the explanted devices and tissue confirm the pigmentation alterations of the tissue and wear on the exterior side of the poly insert.However, the root cause of the reported issue of early poly wear and friction of the metal components cannot be confirmed as it is not known what the femoral head would have articulated with that would give the wear unless a foreign debris was between the head and liner.Information around the ¿possible infection¿ was not reported to conclude if it was diagnosed or ruled out.Thus, our assessment of the provided image of the removed tissue does not contribute to the confirmation (or findings) of an infection.Without the requested surgical reports, it is unknown whether the initial implant positioning or migration over time led to the reported wear of the poly insert and friction of the metal components resulting in the metallosis and subsequent revision surgery.A review of the production order 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 device did not reveal similar events for the listed device.A review of the instructions for use documents for total hip systems revealed that wear of the polyethylene, metal and ceramic articulating surfaces of acetabular components may occur as an adverse event.Higher rates of wear may be initiated by the presence of particles of cement, metal, or other debris which can develop during or as a result of the surgical procedure and cause abrasion of the articulating surfaces.This has been identified as an adverse event.A review of the risk management file 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.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 specifications at the time of manufacture.Factors that could contribute to the reported event include irregular implant interaction, abnormal motion over time or patient condition.Based on this investigation, the need for corrective action is not indicated.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 20 DEG XLPE ACET LNR 32MM X 48MM
• 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: 17936099
• Report Number: 1020279-2023-01942
• Device Sequence Number: 6455517
• Product Code: JDI
• UDI-Device Identifier: 03596010598479
• UDI-Public: 03596010598479
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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 Catalogue Number: 71337648
• Device Lot Number: 21JM11577
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71335548 / LOT NUMBER: 21CW00021; 71336500 / LOT NUMBER: 17EM19884
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 85 KG