MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML LG STATURE 16.5MM; AML IMPLANT : HIP FEMORAL STEM

Model Number	1554-02-165
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Fatigue (1849); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Dizziness (2194); Distress (2329); Ambulation or Postural Difficulties (2544); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.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
Pinnacle poly on metal medical record received.After review of the medical records the patient was revised to address pain, difficulty with function mobility, metallosis, polyethylene wear, tear, trunnionosis and high level of metal ions in his blood.Operative note reported some fluid, black tissue that was removed.There was significant trunnionosis.Synovium was removed approx.30 minutes.Doi: (b)(6) 2011 , 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.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Device history lot : a worldwide complaint database search found no additional related reports against the provided product code/lot number combination.Based on the inability to find any additional related reports against the provided product code/lot number combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.H10 additional narrative: added: h6 clinical symptoms code: appropriate term/code not available (e2402) used to capture blood heavy metal increased.
Event or Problem Description
Litigation alleges pain, loss of balance, dizziness, difficulty walking, stomach upset, deterioration and failure of the product, elevated metal ions, abrasion of the metal on metal components with the bearing causing metal debris in the body, tissue dehiscence, necrosis, hypertrophic scarring, antalgia, lumbar strain, fatigue, limited adl and emotional distress.Doi: (b)(6) 2011; dor: (b)(6) 2020; unknown hip.
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.Appropriate term / code not available ((b)(4)) is utilized to capture blood heavy metal increased.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: AML LG STATURE 16.5MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12631211
• Report Number: 1818910-2021-22710
• Device Sequence Number: 16999484
• Product Code: LPH
• UDI-Device Identifier: 10603295058380
• UDI-Public: 10603295058380
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2021

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 Model Number: 1554-02-165
• Device Catalogue Number: 155402165
• Device Lot Number: DK5C61000
• 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: 10/03/2021
• Supplement Date Received by Manufacturer: 12/22/2021; 01/04/2022
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 12/28/2021; 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2009
• 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: 56X 36 POLY LINER; AML LG STATURE 16.5MM; ARTICULEZE M HEAD 36MM +15.5; PINNACLE 300 ACET CUP 56MM; 56X 36 POLY LINER; AML LG STATURE 16.5MM; ARTICULEZE M HEAD 36MM +15.5; PINNACLE 300 ACET CUP 56MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male