MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number	71338952
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a thr had been performed on (b)(6) 2010, the patient suffered a fall resulting in pain in the affected hip.A revision surgery was performed on (b)(6) 2023 to address this event.In addition, there did not appear to be any damage to the forte femoral head, however the r3 36mm id us crmc liner 52mm was fractured.The components were replaced with a r3 20 degree xlpe liner and a zimmer +7mm sleeved 36 delta head.Patient was scheduled to be discharged day of surgery.
Additional Manufacturer Narrative
Complaint reference number: (b)(4).
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.However, the clinical/medical investigation concluded that the x-ray image provided confirms the breakage in the right acetabular implant.Although medical records were not received for this complaint, it is noted the patient sustained a fall and it cannot be ruled out as precipitating factor to the reported device fracture.Therefore, it cannot be concluded the reported events were associated with a mal performance of the implant or implant failure.The patient impact beyond the reported revision could not be determined.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 reflection/r3 ceramic acetabular system revealed in the warnings and precautions section that the patient should be warned of the brittle nature of the ceramic components and the possibility of failure of the device leading to additional surgery in the future.The patient should be warned that the implant can break or become damaged as a result of strenuous activity or trauma including extreme activity or heavy labor for occupation or recreation.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.According to design rationale for r3 acetabular system, the r3 system¿s design of biolox forte with the titanium band has a superior burst load.The support ring offers greater protection against chipped edges and tensile forces for the ceramic insert that result in high fatigue and burst performance for insert assembly.Lab tests have shown that the burst strength of these liners is significantly higher than that of traditional ceramic liners with no band, therefore, these liners with titanium band may reduce the incidence of fracture of the ceramic liners.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 patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.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 36MM ID US CRMC LINER 52MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: 16975971
• Report Number: 1020279-2023-01090
• Device Sequence Number: 16723894
• Product Code: MRA
• UDI-Device Identifier: 00885556021552
• UDI-Public: 885556021552
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2023
• 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): 06/19/2023

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: 71338952
• Device Lot Number: 08MT26982
• 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: 04/28/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 06/19/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 79 KG