MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 6 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number 1012-14-060

Device Problem Degraded (1153)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Test Result (2695); No Code Available (3191)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).A follow up will be conducted to provide the legal plaintiff information for the initial reporter once the details are provided.Initial reporter occupation: medical professional provided until plaintiff information is received.(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

Pinnacle medical records received.After review of medical records patient was revised to addressed mild to moderate adverse local tissue response with no frank necrosis of tissues outside of the joint nor pseudotumor formation.Operative notes indicated pain, elevated chromium and cobalt levels, taper of the head on to the trunnion had quite a bit of corrosion.Doi: (b)(6) 2008 - dor: (b)(6) 2020 (right hip).

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.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 : 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: TRI-LOCK BPS SZ 6 HI 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: 10829190
• MDR Text Key: 215911952
• Report Number: 1818910-2020-24417
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295001089
• UDI-Public: 10603295001089
• Combination Product (y/n): N
• PMA/PMN Number: K073570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012-14-060
• Device Catalogue Number: 101214060
• Device Lot Number: CF8A21000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 10/24/2020; 12/04/2020
• Supplement Dates FDA Received: 11/13/2020; 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 12/14 ARTICUL 40MM M SPEC+5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT40IDX60OD; PINNACLE SECTOR II CUP 60MM; 12/14 ARTICUL 40MM M SPEC+5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT40IDX60OD; PINNACLE SECTOR II CUP 60MM
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR