MAUDE Adverse Event Report: 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC LPS UNIV TIB HIN INS XSM 14MM; KNEE OTHER IMPLANT

Catalog Number	198727114
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032)
Date of Event	04/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 presented to the emergency department on (b)(6) 2017 due to right knee pain, swelling, redness and drainage for 3 days, fever, and decreased range of motion.Patient had previously had right knee revision surgery on (b)(6) 2017.Patient has a complicated and long surgical history of right knee.I&d and revision occurred on (b)(6) 2017 due to infection.At time of revision the surgeon noted copious amounts of obvious frank pus within the knee joint space.Devitalized tissue and infected tissue was seen throughout.Thorough debridement and irrigation was performed.Multiple products were explanted and replaced.At 2 week post-op assessment on (b)(6) 2017 patient shows no sign on infection.The right knee wound is continuing to heal with some erythema surrounding the incision which appears to be somewhat from the wound vac placement, which has been removed.The swelling of the right knee has decreased substantially.
Additional Manufacturer Narrative
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.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LPS UNIV TIB HIN INS XSM 14MM
• Common Device Name: KNEE OTHER IMPLANT
• Manufacturer (Section D): 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6731533
• Report Number: 1818910-2017-21498
• Device Sequence Number: 762388
• Product Code: KRO
• UDI-Device Identifier: 10603295079408
• UDI-Public: 10603295079408
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2017

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: 07/01/2021
• Device Catalogue Number: 198727114
• Device Lot Number: C64603
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 07/28/2017
• 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: 58 YR
• Patient Weight: 113