MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 18MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number	1987-27-118
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Disorder (2373); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient received a lps distal femoral replacement on the (b)(6) 2019.Patient was unable to achieve full extension, so the surgeon decided to revise the insert to a thinner size.Revised implant information is as follows: lps tibial insert hinge universal 12mm ref: 1987-27-112, lot: j27w26.If other, describe : n/a, if other, describe : revision knee - insert exchange., patient status/ outcome / consequences : yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?: fixed flexion deformity, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: : yes, if yes, describe : revision to thinner insert , other information : n/a, is the patient part of a clinical study : unknown, (b)(4).Device property of: patient, device in possession of: royal perth bio-engineering by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.: true.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary :no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.

• Brand Name: LPS UNIV TIB HIN INS XSM 18MM
• Common Device Name: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10351103
• Report Number: 1818910-2020-17285
• Device Sequence Number: 11454870
• Product Code: KRO
• UDI-Device Identifier: 10603295079422
• UDI-Public: 10603295079422
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2020

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 Model Number: 1987-27-118
• Device Catalogue Number: 198727118
• Device Lot Number: H63634
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 08/31/2020
• 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: LPS UNIV TIB HIN INS XSM 18MM; LPS XX-SM HINGE PIN
• Outcome Attributed to Adverse Event: Required Intervention