MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 54; PRSTHSIS,HIP,SMICONSTRAIND,MTAL/CRMIC/CRMIC/MTL,CMNTED OR UNCEMENTED

Model Number	71338954
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the biolox forte ceramic liner was broken.A revision surgery was performed to remove this device.
Additional Manufacturer Narrative
The associated device, used in treatment was not returned.A review of the device information provided indicates that the reported device was part of field action initiated in 2011.It was identified that the manufacturing process completed for several batches of r3 ceramic liners may have created a lower than expected strength for the liners.It is unclear if the device involved in this complaint failed as a result of this previously identified issue as the device was not returned for evaluation.Possible causes could include but not limited to manufacturing process error.Based on this investigation, the need for corrective action was previously implemented.Without clinical documents and the actual device involved, our investigation cannot proceed.No additional actions are being taken at this time.We consider this investigation closed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: R3 36MM ID US CRMC LINER 54
• Common Device Name: PRSTHSIS,HIP,SMICONSTRAIND,MTAL/CRMIC/CRMIC/MTL,CMNTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9861827
• Report Number: 1020279-2020-00980
• Device Sequence Number: 2663776
• Product Code: MRA
• UDI-Device Identifier: 00885556021927
• UDI-Public: 00885556021927
• 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 Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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 Expiration Date: 06/28/2019
• Device Model Number: 71338954
• Device Catalogue Number: 71338954
• Device Lot Number: 09FT32751
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 11/15/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 11/20/2020
• 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