MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS COMP RP INSERT LG 15MM; LCS COMPLETE : KNEE TIBIAL INSERT

Catalog Number	129405615
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Osteolysis (2377); No Code Available (3191)
Date of Event	03/25/2019
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
Minor revision of lcs total knee replacement.Original surgery was (b)(6) 2009.Patient presented to surgeon with progression of arthritis to patella which was not resurfaced at the time of original surgery.Patient was also experiencing swelling and pain.Some lysis was observed on xray.Surgeon performed revision surgery to resurface the patella, take specimens for pathology and exchange the tibial insert.Original insert was removed and some minor poly wear was observed.Specimens were taken, a trial insert was placed to confirm appropriate joint stability, and then the patella was resected and prepared for resurfacing.A new large 15mm lcs insert and large all-poly patella were implanted and the wound was washed out with pulse lavage and closed.Patient status/outcome/consequences: no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: no.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > the complaint was received into the company with the comment: minor revision of lcs total knee replacement.Original surgery was (b)(6) 2009.Patient presented with progression of arthritis to patella which was not resurfaced at the time of original surgery.Patient was also experiencing swelling and pain.Some lysis was observed on x-ray.Surgeon performed revision surgery to resurface the patella, take specimens for pathology and exchange the tibial insert.Original insert was removed and some minor poly wear was observed.Specimens were taken, a trial insert was placed to confirm appropriate joint stability, and then the patella was resected and prepared for resurfacing.A new large 15mm lcs insert and large all-poly patella were implanted and the wound was washed out with pulse lavage and closed." doi: (b)(6) 2009; dor: (b)(6) 2019; right side.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCS COMP RP INSERT LG 15MM
• Common Device Name: LCS COMPLETE : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8520061
• Report Number: 1818910-2019-90833
• Device Sequence Number: 13831754
• Product Code: NJL
• UDI-Device Identifier: 10603295022176
• UDI-Public: 10603295022176
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 129405615
• Device Lot Number: B27NC4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 06/03/2019
• 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: Required Intervention
• Patient Age: 68 YR