MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 8 STD OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number 1012-04-080

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

Patient Problems Atrial Fibrillation (1729); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Ischemic Heart Disease (2493); Ambulation Difficulties (2544); Pericardial Effusion (3271); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.(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

Ppf, pfs and medical records received.Ppf has no allegation.Pfs alleges pain, gain weight, dm, heart issues, walking difficulty, decrease rom, metallosis and patient suspect metal in blood caused memory impairment.After review of medical records, no revision was scheduled due to diabetes and heart condition as well as throat issue, patient could not be intubated and that a revision surgery would be out of the question.Patient also reported concerns about metallosis.Doi: (b)(6) 2008.Dor: none reported.Left hip.

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 material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative.

• Brand Name: TRI-LOCK BPS SZ 8 STD OFFSET
• Type of Device: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11661002
• MDR Text Key: 245350745
• Report Number: 1818910-2021-07853
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295000792
• UDI-Public: 10603295000792
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2021

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: 1012-04-080
• Device Catalogue Number: 101204080
• Device Lot Number: CK7J31000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 04/28/2021; 08/09/2021
• Supplement Dates FDA Received: 04/28/2021; 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 40MM M SPEC-2; PINNACLE 300 ACET CUP 58MM; PINNACLE MTL INS NEUT40IDX58OD; TRI-LOCK BPS SZ 8 STD OFFSET; 12/14 ARTICUL 40MM M SPEC-2; PINNACLE 300 ACET CUP 58MM; PINNACLE MTL INS NEUT40IDX58OD; TRI-LOCK BPS SZ 8 STD OFFSET
• Patient Outcome(s): Required Intervention