MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS SM 12MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number	1987-27-212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Edema (1820); Muscular Rigidity (1968); Pain (1994); No Code Available (3191)
Date of Event	09/25/2020
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
Revision: (b)(6) hospital (b)(6) 2020 reason for revision: anterior knee pain and stiffness.Patella not previously done.Patient has had several revisions done on her knee by three different surgeons.For some reason the patella had not been resurfaced with this case.Patient presented with anterior knee pain and stiffness.Patient was left in 5 degrees of valgus from previous revision surgery.On removal of insert it was clear synovial fluid had infiltrated the poly and was visible in the bottom.Jnj rep was present for the case.Female patient.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Confirmed no malpositioning of an implanted depuy product.Implant was well aligned; however the hinge bearing was no longer rotating due to osteophytes/heterotopic bone formation.Sales rep also mentioned that hinge pin was removed, femur and tibial components preserved and a new insert/old pin used.Left side was the affected side in this event.Old hinge pin removed and reused with new insert.Surgeon was encouraged to use new pin but felt the old one was in perfect condition and no sign of infection.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the received device was forwarded to commercialized product development for evaluation.Review of the received device was unable to confirm the reported event.The investigation found no evidence of product malfunction or product error and the need for corrective action was not established.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not visible on the device and was not provided with the report.

• Brand Name: LPS UNIV TIB HIN INS SM 12MM
• 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: 10663048
• Report Number: 1818910-2020-21955
• Device Sequence Number: 4044765
• Product Code: KRO
• UDI-Device Identifier: 10603295079484
• UDI-Public: 10603295079484
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2020

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: 1987-27-212
• Device Catalogue Number: 198727212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 10/14/2020; 12/07/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 10/27/2020; 12/08/2020
• 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 XX-SM HINGE PIN
• Outcome Attributed to Adverse Event: Required Intervention