MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE DISHED ISRT SZ 5-6 9MM; PRSTHSS,KNEE,PTLLFMRTBL,SMICNSTRND,CMNTD,PLYMRMTLPLYMR

Catalog Number	71453284
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	10/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to remove the dished insert due to pain.Doctor doesn't blame the implant to be the cause of the pain.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.The following are the results of our investigation: 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 clinical analysis that based on the available information, a root cause for the ¿pain¿ that precipitated the revision this patient experienced cannot be concluded.No patient clinical/medical information had been provided at this time.Should any relevant information become available this complaint can be re-assessed.A review of complaint history on the listed parts revealed no additional complaints for the listed batches.Without the actual product involved and/or device information, our investigation cannot proceed.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: LGN XLPE DISHED ISRT SZ 5-6 9MM
• Common Device Name: PRSTHSS,KNEE,PTLLFMRTBL,SMICNSTRND,CMNTD,PLYMRMTLPLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6999906
• Report Number: 1020279-2017-00975
• Device Sequence Number: 13827068
• Product Code: JWH
• UDI-Device Identifier: 00885556255643
• UDI-Public: 00885556255643
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

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: 04/14/2024
• Device Catalogue Number: 71453284
• Device Lot Number: 14DM13901
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/03/2017
• Supplement Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART:71420168 / LOT:16FT72141; PART:71932636 / LOT:16HM13677
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention