MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 56; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL

Catalog Number	71338956
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to the patient having a traumatic injury and shattering the ceramic liner.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A lab analysis investigation of the returned components did not include any destructive testing.The returns included seven fragments of the ceramic liner.This may not represent the entire volume of the ceramic liner.As reported; the patient had a traumatic injury, which resulted in the fracturing of the ceramic liner.The condition and size of the fragments do not provide any information to support any other conclusion about the fracture.Visual inspection of the outer metal support ring found some physical wear and deformation.Damage to the ring most likely occurred after the fracture of the ceramic liner.The length of time between the ceramic liner fractured and when the revision surgery occurred is not included in the reports.Examination of the femoral head suggest the revision surgery did not occur immediately after the fracture of the ceramic liner.There is a large area of metal transfer on the articular surface of the head and is the result of contact with a metal component over some period of time.Most likely, this is the result of contact with the metal ring as there is no indication or report of issues with the r3 shell which was not returned.For the purpose of record, the ceramtec (ceramic vendor) lot control number.There is no record or evidence of any deviation of materials or manufacturing processing found during this investigation.From the visual inspections of the component and all information reported, other than the trauma experienced by the patient, no other conclusion can be made as the reason for the ceramic liner fracture.A clinical evaluation revealed no relevant clinical medical information was provided to conduct a thorough medical assessment.Should information become available this complaint can be re-assessed.Available this complaint can be re-assessed.

• Brand Name: R3 36MM ID US CRMC LINER 56
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8862835
• Report Number: 1020279-2019-02897
• Device Sequence Number: 2534038
• Product Code: MRA
• UDI-Device Identifier: 00885556022115
• UDI-Public: 00885556022115
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71338956
• Device Lot Number: 09DT30739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention