MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OXIN P/S FEM RIGHT SZ 7; PRSTHSS,KNE,PTLLFMRTIIL,SMCNSTRND,CMNTD,PLYRMTLPLYMR

Catalog Number	71421117
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to loosening and infection.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Based on the information available, a root cause for loosening and infection cannot be concluded.A review of complaint history on the listed parts and corresponding batches revealed no prior complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.However, without the actual devices, our investigation cannot proceed.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: GII OXIN P/S FEM RIGHT SZ 7
• Common Device Name: PRSTHSS,KNE,PTLLFMRTIIL,SMCNSTRND,CMNTD,PLYRMTLPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7457305
• Report Number: 1020279-2018-00813
• Device Sequence Number: 19096737
• Product Code: JWH
• UDI-Device Identifier: 03596010469311
• UDI-Public: 03596010469311
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K962557
• 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): 11/22/2018

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: 08/15/2026
• Device Catalogue Number: 71421117
• Device Lot Number: 16HM11900
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2018
• Supplement Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 11/22/2018
• 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