MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 AML 10.5 STD 6.3 5/8 STD 12/14; AML IMPLANT : HIP FEMORAL STEM

Model Number	1554-02-000
Medical Device Problem Codes	Fracture (1260); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	01/01/2020
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
Surgeon reported to (b)(6): "transferral from orthopedic outpatient department because of stem fracture - prosthesis with signs of loosening.No trauma in anamnesis.Revision of stem to modular cementless stem with wire-osteosynthesis on (b)(6) 2020.".
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.If information is obtained that was not available for the initial report, a follow-up report 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.¿.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : examination of the returned device confirms the reported material fracture.The device was evaluated by a depuy material scientist.No material or manufacturing defects were observed in the femoral stem that could have contributed to the fracture.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 bs2a11.The device manufacturing records and material certs for this product/lot combination were reviewed.No deviations or anomalies were observed.Device history review the device manufacturing records and material certs for this product/lot combination were reviewed.No deviations or anomalies were observed.H10 additional narrative:.
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 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.Re-captured patient code.No code available (3191) was used to capture device revision or replacement.Removed code for fracture.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
Affected side: right.

• Brand Name: AML 10.5 STD 6.3 5/8 STD 12/14
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10098478
• Report Number: 1818910-2020-12804
• Device Sequence Number: 14109790
• Product Code: LPH
• UDI-Device Identifier: 10603295058311
• UDI-Public: 10603295058311
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K953694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/14/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1554-02-000
• Device Catalogue Number: 155402000
• Device Lot Number: BS2A11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 06/04/2020; 07/08/2020; 08/04/2020; 09/08/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 06/08/2020; 07/16/2020; 08/04/2020; 09/09/2020
• 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: ENDURON 10D 50OD X 28ID; HIP BA BIO 28MM 12/14 + 1.5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 75