MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS SM 16MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Catalog Number 198727216

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Synovitis (2094); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

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.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.

Event Description

Patient of (b)(4) will undergo another revision of right knee in early (b)(6) 2020 because of unknown reason.Doi: (b)(6) 2016.Dor (first revision, (b)(4)): (b)(6) 2019.Dor (second revision, (b)(4)): (b)(6) 2020.

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: added: d2b, d4 (procode, lot, exp, udi).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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 SM 16MM
• Type of Device: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9865279
• MDR Text Key: 187870832
• Report Number: 1818910-2020-08814
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K091453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 198727216
• Device Lot Number: H43099
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: 08/17/2020; 09/08/2020
• Supplement Dates FDA Received: 09/02/2020; 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LPS XX-SM HINGE PIN; SROM* BUMPER NOILES MOD SML; SROM* BUMPER NOILES MOD SML; SROM*NRH REPL HINGE PIN/XSM/SM; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE TIBIAL INSERT
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR