MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 12/14 ARTICUL 40MM M SPEC+8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-07-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Distress (2329); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Litigation alleges toxic levels of metal ions in the tissue, bone, joint, blood stream causing destruction, pain and emotional distress.Doi: (b)(6) 2008.Dor: (b)(6) 2020.Left 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.Initial reporter occupation: lawyer.(b)(4).
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: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.H6 clinical code: unspecified tissue injury (e2015) is used to capture soft tissue injury and bone injury.
Event or Problem Description
After review of the operative notes and sticker sheets, patient was revised due to metallosis, pain similar trochanteric bursitis.The patient had a leg length discrepancy to begin with.Patient stated he felt like it was about a quarter of an inch when he was asleep.The hip was stable and has erosion at the head and neck junction.Doi: (b)(6) 2010, dor: (b)(6) 2020, affected side: left hip.

• Brand Name: 12/14 ARTICUL 40MM M SPEC+8.5
• 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13235259
• Report Number: 1818910-2022-00576
• Device Sequence Number: 16783337
• Product Code: LPH
• UDI-Device Identifier: 10603295033004
• UDI-Public: 10603295033004
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022
• 2 Devices were Involved in the Event: 1 2

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: 03/31/2014
• Device Model Number: 1365-07-000
• Device Catalogue Number: 136507000
• Device Lot Number: 2880671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INNACLE MTL INS NEUT40IDX56OD; PINN CAN BONE SCREW 6.5MMX30MM; PINNACLE SECTOR II CUP 56MM; TRI-LOCK BPS SZ 5 HI OFFSET; UNK HIP ACETABULAR LINER METAL PINNACLE; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male