MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*NRH REPL HINGE PIN/XSM/SM; BONE SCREWS AND PINS : KNEE TIBIAL INSERT ACCESSORY

Catalog Number 621640

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Edema (1820); Pain (1994); Swelling (2091); Hypoesthesia (2352); Joint Disorder (2373); No Code Available (3191)

Event Date 08/22/2019

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.

Event Description

Revision of s-rom noiles rotating hinge inlay right side as patient suffered pain and instability.Date of initial surgery: 2016, date of revision: (b)(6) 2019.Surgeon found the inlay`s pe-ring (see picture) worn.A surgical delay was not reported.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #
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> (b)(4).Investigation summary
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> following review of the information received, it was concluded that it was not possible to determine if a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.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.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).H6 device codes: no code available was intended for medical device removal.

• Type of Device: BONE SCREWS AND PINS : KNEE TIBIAL INSERT ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9088209
• MDR Text Key: 162343182
• Report Number: 1818910-2019-105477
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10603295179108
• UDI-Public: 10603295179108
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/22/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 621640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 11/08/2019; 11/13/2019; 11/20/2019
• Supplement Dates FDA Received: 11/15/2019; 11/18/2019; 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPETITOR CEMENT; COMPETITOR CEMENT; COMPETITOR CEMENT; LPS UNIV TIB HIN INS SM 12MM; MBT REV TIB TRAY SIZE 3 15MM; MBT TRAY SLEEVE POR M/L 45MM; SROM NRH DIST AUG XS/S/MD 10MM; SROM NRH DIST AUG XS/S/MD 10MM; SROM NRH DIST AUG XS/S/MD 5MM; SROM NRH DIST AUG XS/S/MD 5MM; SROM NRHFEM W/PIN SM RT 66X62; UNIVERSAL FEM SLV FUL POR 46MM; UNIVERSAL STEM 115X14MM FLUTED; UNIVERSAL STEM 75X20MM FLUTED
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR