MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN XLPE DISHED ISRT SZ 7-8 13MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	71453293
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	01/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery of the poly insert due to rupture of posterior cruciate ligament and instability.No delay to procedure was reported.
Additional Manufacturer Narrative
The clinical/medical team concluded, based on the limited information provided and without the return of the device for analysis the root cause of the reported rupture of posterior cruciate ligament and instability cannot be determined.Based on the information received the rash was due to contact dermatitis which started following the removal of the surgical dressing.It was also reported that the pain the patient experienced post revision was due to a retained staple following implantation.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re opened.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Proceed based on information provided/available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by (b)(6) medical director.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information.Surgical procedure/post-operative care review.Device labeling (including technique guides, ifus, etc.) conclusion: (b)(6): based on the limited information provided and without the return of the device for analysis the root cause of the reported rupture of posterior cruciate ligament and instability cannot be determined.However, an injury to the posterior cruciate ligament trauma cannot be ruled out.(b)(6) based on the information received the rash was due to contact dermatitis which started following the removal of the surgical dressing.It was also reported that the pain the patient experienced post revision was due to a retained staple following implantation.Neither event is due to failure of the sampn device.Approved by (b)(6), md on (b)(6) 2019.

• Brand Name: LGN XLPE DISHED ISRT SZ 7-8 13MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8348220
• Report Number: 1020279-2019-00630
• Device Sequence Number: 2106465
• Product Code: JWH
• UDI-Device Identifier: 00885556255568
• UDI-Public: 00885556255568
• 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: 2014
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2019

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 Expiration Date: 06/11/2022
• Device Catalogue Number: 71453293
• Device Lot Number: 12FM08240
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 06/15/2019
• 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: Hospitalization; Required Intervention