MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII NON-MOD CEM C/R FEM SZ7 LT; PRSTHIS,KNEE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMR/MTL/PLYMR

Catalog Number	71420076
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed because cement didn¿t adhere to the femoral component causing it to fell off.
Additional Manufacturer Narrative
The associated device was not returned for evaluation.No relevant supporting clinical information has been provided to assist with a clinical investigation, and there is no report of the patient's current condition.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.A review of manufacturing records did not reveal any deviations that could have contributed to the reported issue.A review of complaint history did not reveal any previous complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.If additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII NON-MOD CEM C/R FEM SZ7 LT
• Common Device Name: PRSTHIS,KNEE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7288917
• Report Number: 1020279-2018-00228
• Device Sequence Number: 13795015
• Product Code: JWH
• UDI-Device Identifier: 03596010205827
• UDI-Public: 03596010205827
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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: 08/27/2022
• Device Catalogue Number: 71420076
• Device Lot Number: 12HM17346
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 05/23/2018
• 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: 78 YR