MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 32MM ID US CRMC LINER 50; PROSTHESIS HIP SEMI-CONSTRAINED METAL/CERAMIC/CERAMIC/METAL CEMENTED/UNCEMENTED

Catalog Number	71338950
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to replace a ceramic liner with a poly liner.No failure specified.No delay or additional injuries reported.
Additional Manufacturer Narrative
The affected r3 32mm ceramic liner was not returned for evaluation.Our investigation including a review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.The device was manufactured in 2009.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.However, it was communicated that although nothing was wrong with the ceramic liner it was exchanged for a poly liner.No further information was provided, therefore the root cause for the liner exchange remains unknown.The patient impact beyond the revision surgery itself and an expected brief post-operative convalescence period cannot be determined.No further medical assessment is warranted at this time.Without the return of the actual products involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: R3 32MM ID US CRMC LINER 50
• Common Device Name: PROSTHESIS HIP SEMI-CONSTRAINED METAL/CERAMIC/CERAMIC/METAL CEMENTED/UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8123194
• Report Number: 1020279-2018-02638
• Device Sequence Number: 13866347
• Product Code: MRA
• UDI-Device Identifier: 00885556020661
• UDI-Public: 00885556020661
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

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: 71338950
• Device Lot Number: 09DT30915
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 12/02/2018
• Supplement Report FDA Received Date: 02/07/2019
• 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