MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AML LG STATURE 13.5MM; AML IMPLANT : HIP FEMORAL STEM

Model Number	1554-02-135
Medical Device Problem Codes	Break (1069); Fracture (1260); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Discomfort (2330); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646); No Code Available (3191); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/28/2017
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
The patient was revised to address femoral stem loosening at the bone to implant interface.It was also stated that femoral stem broke.Doi: (b)(6) 2009;dor: (b)(6) 2017;unknown affected site.
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for examination.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).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4) used to capture the surgical intervention and medical device removal.
Event or Problem Description
Aml litigation records received alleging pain, component fracture (stem), mental anguish, physical injuries, suffering, medical expenses, economic loss, loss of enjoyment of life, impairment and disfigurement.Doi: (b)(6) 2009 - dor: (b)(6) 2017; (left hip).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.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: null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate removed h6 (device) break (1069) and (3191) medical device removal and surgical intervention.No code available (3191) is used to capture blood heavy metal increased and device revision or replacement.
Event or Problem Description
After review of medical records, the patient complaints of pain in the left hip and groin, as well as low back pain and radiating pain.X-ray result showed fracture of the left femoral stem.The patient was using crutches for ambulation due to increased pain with weight-bearing.The patient was then revised for broken femoral stem aml with associated metal on metal articulation, left hip.Operative notes reported that there was a thick white scar tissues.
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 clinical code: appropriate term/ code not available (e2402) is used 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.
Event or Problem Description
On (b)(6) 2009, the patient had bilateral total hip arthroplasties to address severe bilateral hip arthritis.Depuy components were used during this procedure.On (b)(6) 2017, the patient had a revision femoral stem of left total hip arthroplasty, and exchange of metal liner to polyethylene to address broken (fractured) femoral stem aml with associated metal-on-metal articulation.The indications for surgery noted that the patient was having pain, cobalt and chromium levels were 14.During the procedure, the surgeon observed quite a bit of really thick white scar tissue.The proximal portion femoral stem was noted to be loose and easily removed.The distal portion of the stem was well fixed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation.The x-ray investigation was performed from the x-ray attached and the discs provided, fracture on the left stem can be seen, however nothing indicative that would indicate loosening was found.The reported allegation can be confirmed partially.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: AML LG STATURE 13.5MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 7133050
• Report Number: 1818910-2017-52122
• Device Sequence Number: 11090524
• Product Code: LPH
• UDI-Device Identifier: 10603295058366
• UDI-Public: 10603295058366
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/28/2017
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2018
• Device Model Number: 1554-02-135
• Device Catalogue Number: 155402135
• Device Lot Number: C74KS1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 01/26/2018; 11/11/2019; 12/17/2019; 07/02/2020; 02/15/2022; 02/25/2022; 01/30/2023; 02/09/2023
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 01/26/2018; 12/04/2019; 12/19/2019; 07/12/2020; 02/18/2022; 03/10/2022; 02/07/2023; 02/10/2023
• Date Device Manufactured: 12/18/2008
• 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: ACET PINN W/GRIPTION CUP 52MM; ARTICULEZE M HEAD 36MM +8.5; PINNACLE MTL INS NEUT36IDX52OD; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 85 KG