MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CEMENT RESTRICTOR SIZE 4; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG

Model Number 5460-16-000

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

Patient Problems Pain (1994); Joint Laxity (4526)

Event Date 12/20/2021

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

It was reported that this patient's previously revised knee was revised a second time due to pain and instability.The patient's attune revision knee components were removed and replaced by an s-rom noiles hinged femur, an lps hinged rp insert, and a sigma revision mbt tibial tray.Depuy smartset medium viscosity bone cement would have been used in the prior revision procedure, since the hospital only stocks smartset cement.The product codes and lot numbers for the cement is not available, since the cement used was hospital inventory ordered directly from depuy.Doi: (b)(6) 2020, dor: (b)(6) 2021, right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: CEMENT RESTRICTOR SIZE 4
• Type of Device: HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13170669
• MDR Text Key: 283292097
• Report Number: 1818910-2022-00235
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295174356
• UDI-Public: 10603295174356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 5460-16-000
• Device Catalogue Number: 546016000
• Device Lot Number: HP2457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE CEMENTED STEM 14X30MM.; ATTUNE CRS FEMORAL RT SZ 5 CEM.; ATTUNE CRS RP INSRT SZ 5 20MM.; ATTUNE DIST FEM AUG SZ 5 4MM.; ATTUNE DIST FEM AUG SZ 5 4MM.; ATTUNE POS FEM AUG SZ 5 8MM.; ATTUNE POS FEM AUG SZ 5 8MM.; ATTUNE SOLO PINNING SYSTEM.; ATUN PRESSFIT STR STEM12X110MM.; ATUN TIB AUG LM/RL SZ 5/6 10MM.; ATUN TIB AUG RM/LL SZ 5/6 10MM.; ATUN TIB SLV M/L 29MM FULL POR.; ATUNE REV RP TIB BASE SZ 5 CEM.; UNK CEMENT SMARTSET MV.
• Patient Outcome(s): Required Intervention; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male