MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 36MM ID US CRMC LINER 56; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Catalog Number	71338956
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a broken liner.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.The medical investigation concluded that, without the requested clinical information, a thorough medical investigation cannot be rendered.Should any additional clinical information be provided, this complaint will be re-assessed.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: R3 36MM ID US CRMC LINER 56
• Common Device Name: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9013263
• Report Number: 1020279-2019-03335
• Device Sequence Number: 19553892
• Product Code: JDH
• UDI-Device Identifier: 00885556022115
• UDI-Public: 00885556022115
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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 Expiration Date: 04/28/2019
• Device Catalogue Number: 71338956
• Device Lot Number: 09DT30970
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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