MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC+12; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-08-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); No Code Available (3191); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
This case is being logged from additional information received in case (b)(4).The patient is seriously ill with suspected metallosis.Head exchange on 10th aug captured on (b)(4).Patient was due to have all components explanted on the 5th october.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Review of the provided x-ray image is unable to confirm the reported allegation or determine a root cause.No product problem is identified.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 : per (b)(4) it has been determined a dhr review is not required.
Event or Problem Description
It was reported that the patient has had nearly died from metalosis (cobalt poisoning) has had two lots of surgery in 7 weeks.Hip bone is now mush.Muscle is destroyed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Review of the provided x-ray image is unable to confirm the reported allegation or determine a root cause.No product problem is identified.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 : per wi-3430 it has been determined a dhr review is not required.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the soft tissue injury, bone injury and metal poisoning.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Review of the provided x-ray image is unable to confirm the reported allegation or determine a root cause.No product problem is identified.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 : per wi-3430 it has been determined a dhr review is not required.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture blood heavy metal increased.
Event or Problem Description
Pc has been re-opened due to receipt of audit correction, which requested to capture elevated metal ion allegations for the revision on (b)(6) 2020.Hip bone is now mush.Muscle is destroyed was noted to be due to the elevated cobalt levels.

• Brand Name: 12/14 ARTICUL 40MM M SPEC+12
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10811278
• Report Number: 1818910-2020-24249
• Device Sequence Number: 3799457
• Product Code: JDI
• UDI-Device Identifier: 10603295033028
• UDI-Public: 10603295033028
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K060031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/26/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1365-08-000
• Device Catalogue Number: 136508000
• Device Lot Number: 9360172
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 12/10/2020; 03/17/2021; 03/30/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 12/11/2020; 03/29/2021; 04/05/2021
• 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: CORAIL2 LAT COXA VARA SIZE 12; PINNACLE 100 HA ACET CUP 56MM; PINNACLE MTL INS NEUT40IDX56OD; PINNACLE MTL INS NEUT40IDX56OD; CORAIL2 LAT COXA VARA SIZE 12; PINNACLE 100 HA ACET CUP 56MM; PINNACLE MTL INS NEUT40IDX56OD; PINNACLE MTL INS NEUT40IDX56OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR