MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRI-LOCK BPS SZ 4 HI OFFSET; TRILOCK HIP STEM : HIP FEMORAL STEM

Model Number 1012-14-040

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

Patient Problems Anemia (1706); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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

Consumer claim letter received.There is a problem with metal on poly hip replacement system.The patient experienced pain, severe anemia due to cobalt metal poisoning with cobalt levels reaching 9.7 and chromium reaching 1.2 (no units of measurement provided.The patient was originally implanted with metal on poly.The patient was revised (b)(6) 2020.The head/liner were revised.Patient stated that after the revision, their cobalt levels dropped and they were cured of their anemia.Doi: (b)(6) 2016 dor: (b)(6) 2020 right 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 device manufacturing records have been reviewed.No related deviations or anomalies identified.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the metal poisoning and blood heavy metal increased.

• Brand Name: TRI-LOCK BPS SZ 4 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: 11272463
• MDR Text Key: 230044809
• Report Number: 1818910-2021-02331
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295001065
• UDI-Public: 10603295001065
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

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: 1012-14-040
• Device Catalogue Number: 101214040
• Device Lot Number: 624893
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 10D 32IDX52OD; ARTICUL/EZE BALL 32 +5 BR; PINNACLE SECTOR II CUP 52MM; TRI-LOCK BPS SZ 4 HI OFFSET; ALTRX +4 10D 32IDX52OD; ARTICUL/EZE BALL 32 +5 BR; PINNACLE SECTOR II CUP 52MM; TRI-LOCK BPS SZ 4 HI OFFSET
• Patient Outcome(s): Required Intervention