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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anemia (1706); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: TRILOCK HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11272463
• Report Number: 1818910-2021-02331
• Device Sequence Number: 11696735
• Product Code: KWA
• UDI-Device Identifier: 10603295001065
• UDI-Public: 10603295001065
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 1012-14-040
• Device Catalogue Number: 101214040
• Device Lot Number: 624893
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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
• Outcome Attributed to Adverse Event: Required Intervention