MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII OVAL RESURFACING PAT 38MM; PRSTHSI,KNEE,PTLLFMRTIBL,SMI-CNSTRND,CMNTD,PLYMR/METAL/POLYMER

Catalog Number	71421038
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a right knee manipulation was performed due to the patient presented limited range of motion.
Additional Manufacturer Narrative
The associated complaint devices were 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 batches.Without the actual devices involved our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re-opened.The clinical medical investigation concluded that the details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.Based on the information provided, the ¿limited range of motion¿ experienced by the patient was likely a normal progression of the post-operative healing phase and not a failure of the device.Information around the patient¿s post-operative rehabilitation prior to this mua is not available.Since there are no plans for a revision has been reported, no further clinical/medical assessment is warranted at this time.No further actions are being taken at this time.

• Brand Name: GII OVAL RESURFACING PAT 38MM
• Common Device Name: PRSTHSI,KNEE,PTLLFMRTIBL,SMI-CNSTRND,CMNTD,PLYMR/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8292195
• Report Number: 1020279-2019-00347
• Device Sequence Number: 1691192
• Product Code: JWH
• UDI-Device Identifier: 03596010485083
• UDI-Public: 03596010485083
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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 Catalogue Number: 71421038
• Device Lot Number: 18CM17934
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 06/11/2019
• 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: Other; Required Intervention
• Patient Age: 53 YR