MAUDE Adverse Event Report: DEPUY CMW - 9610921 DEPUY1 GENTAMICIN CEMENT 40G; BONE CEMENT : BONE CEMENT

Model Number 5450-31-500

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

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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

It was reported by the patient that she had a total knee replacement and scheduled for arthroscopic surgery on (b)(6), to see of there is anything that can be done to ease the pain and improve her range of motion, which is only 90 degrees and possible allergy to nickle.The customer also mentioned that she made a contact through email about three times but received no response.Doi: (b)(6) 2019 : dor: none reported (unk knee).

Manufacturer Narrative

Product complaint # (b)(4).The device associated with this report was not received for examination.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.

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: d4 (lot).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: the device associated with this report was not received for examination.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.H10 additional narrative:  details for gentamicin component of combination product: dmf# - (b)(4); trade name ¿ gentamicin sulphate; active ingredient(s) ¿ gentamicin sulphate; dosage form - powder; strength ¿ 1.0g active in our cements.

• Brand Name: DEPUY1 GENTAMICIN CEMENT 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 10600960
• MDR Text Key: 209002556
• Report Number: 1818910-2020-21115
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174264
• UDI-Public: 10603295174264
• Combination Product (y/n): N
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5450-31-500
• Device Catalogue Number: 545031500
• Device Lot Number: 9080845
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PFC*SIGMA/OV/DOME PAT 3PEG,35.; SIG MOD TIB TRAY CEM COCR 3.; SIGMA CR150 CEM SZ 3 RT.; SIGMA XLK CVD PLUS INS 3 10MM.; PFC*SIGMA/OV/DOME PAT 3PEG,35; SIG MOD TIB TRAY CEM COCR 3; SIGMA CR150 CEM SZ 3 RT; SIGMA XLK CVD PLUS INS 3 10MM
• Patient Outcome(s): Required Intervention