MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 5; PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMR/MTL/PLYMR

Catalog Number	74021155
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pin of the femur was left inside patient's body.
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 clinical analysis indicated that a review of the provided post-implantation imaging, neither silhouette of the lugs are visualized nor is an unexpected foreign body noted.Per complaint, the surgeon was concerned that loosening and/or migration of the lugs had occurred, however, the lugs would have remained buried within the patient¿s femoral bone if loosening and/or migration had occurred post cement fixation.It is unknown if the lugs were intact prior to cementing.Neither patient harm nor revision was reported; therefore, no further medical investigation is warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batch.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.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.We consider this investigation closed.

• Brand Name: JRNY II CR FEM OX NP RT SZ 5
• Common Device Name: PRSTHSS,KNE,PTLLFMRTBL,SMCNSTRND,CMNTD,PLYMR/MTL/PLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7323166
• Report Number: 1020279-2018-00282
• Device Sequence Number: 104786
• Product Code: JWH
• UDI-Device Identifier: 00885556422847
• UDI-Public: 00885556422847
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2018

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 Catalogue Number: 74021155
• Device Lot Number: 17AM20637
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 06/04/2018
• 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: Other