MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REDAPT SLVLS MONO REV STEM 300MM SZ15 SO; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	71354739
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a disassociation of the head and the stem.The redapt stem was replaced.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to a disassociation of the devices.The redapt stem and the head were removed.The associated redapt femoral standard offset sleeveless stem and biolox head, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.The complaint was reported to ceramtec for the head.As the legal manufacturer of the head, ceramtec will perform the investigation on this part.Our investigation including the review of manufacturing records of the stem did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the stem revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.No medical documents were received for investigation.No further medical assessment can be performed at this time.Possible causes could include but are not limited to lack of engagement with host bone or improper surface texture.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: REDAPT SLVLS MONO REV STEM 300MM SZ15 SO
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9137586
• Report Number: 1020279-2019-03512
• Device Sequence Number: 2694335
• Product Code: LZO
• UDI-Device Identifier: 00885556579602
• UDI-Public: 00885556579602
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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 Model Number: 71354739
• Device Catalogue Number: 71354739
• Device Lot Number: 16ETM0002F
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 04/06/2020
• 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
• Patient Age: 55 YR