MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 12/14 ARTICUL 44MM M SPEC+8.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-63-000
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Erosion (1750); Edema (1820); Foreign Body Reaction (1868); Hemorrhage/Blood Loss/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Synovitis (2094); Tissue Damage (2104); No Code Available (3191)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).
Event or Problem Description
Patient was revised to address metalosis.Metal head and metal liner were removed.Surgeon noted abductor loss due to metalosis.No additional information needed.Doi: unknown dor: (b)(6) 2019, 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.
Additional 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.H6 patient code: no code available (3191) was used to capture limb asymmetry and device revision or replacement.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
After review of medical record, patient was revised to address failed right total hip arthroplasty secondary to bearing wear.Revision notes stated that the hip capsule anteriorly was thickened and there was synovial fluid beneath.Most of the anterior capsule was severely diseased, very inflamed, and thickened with hypertrophic synovium.Synovectomy was performed due to the severity of soft tissue damage.The head and liner were removed.There was corrosion at the trunnion.Clinical visits prior to the revision stated that patient had a large pseudotumor with metal synovitis.Operative findings stated that the heterotopic bone was removed.The metal synovitis had eroded.There was necrotic soft tissue.The leg was lengthened slightly due to loss of soft tissue.Bleeding was minimal.Doi: (b)(6) 2009 - dor: (b)(6) 2019 (right hip).

• Brand Name: 12/14 ARTICUL 44MM M SPEC+8.5
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; depuy orthopaedics, inc. 18189; 700 orthopaedic drive IN 46582 0988
• MDR Report Key: 8439418
• Report Number: 1818910-2019-87972
• Device Sequence Number: 16648027
• Product Code: LPH
• UDI-Device Identifier: 10603295034117
• UDI-Public: 10603295034117
• 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: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/01/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2012
• Device Model Number: 1365-63-000
• Device Catalogue Number: 136563000
• Device Lot Number: 2468682
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 04/04/2019; 07/08/2020; 07/21/2020
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 04/10/2019; 07/20/2020; 07/23/2020
• 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: APEX HOLE ELIM POSITIVE STOP.; CORAIL2 STD SIZE 16.; PINNACLE 100 ACET CUP 62MM.; PINNACLE MTL INS NEUT44IDX62OD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR