MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CEMENTRALIZER 12.0; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG

Model Number 1376-21-000

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Code Available (3191)

Event Date 03/10/2020

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.

Event Description

It was reported that the patient had dislocation issues, after incision the doctor found the stem to be loose.Original implant date unknown.Doi: unknown.Dor: (b)(6) 2020, affected site: left hip.

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 # (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 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CEMENTRALIZER 12.0
• Type of Device: HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9890147
• MDR Text Key: 185919892
• Report Number: 1818910-2020-09487
• Device Sequence Number: 1
• Product Code: LTO
• UDI-Device Identifier: 10603295034452
• UDI-Public: 10603295034452
• Combination Product (y/n): N
• PMA/PMN Number: K871510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

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 Model Number: 1376-21-000
• Device Catalogue Number: 137621000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 03/27/2020
• Supplement Dates Manufacturer Received: 05/05/2020
• Supplement Dates FDA Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 10D 36IDX52OD; APEX HOLE ELIM POSITIVE STOP; CEMENTRALIZER 12.0; DLT TS CER HD 12/14 36MM +1.5; PINN SECTOR W/GRIPTION 52MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; SUMMIT CEMENTED STEM SZ7 STD
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR