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 Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Hcp is reporting to nca/bfarm: "pain left thigh and hip since years.Fall in domicile on (b)(6) 2023, then the entire night lying on the floor.Nursing service found patient the next morning and picked him up.Another fall on (b)(6)2023.Now presentation in the hospital radebeul.There in the x-ray a stem-fracture was diagnosed.Transfer to dresden municipal hospital, orthopedics for further care.Revision surgery with replacement of the stem on (b)(6) 2023.".
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).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: the device associated with this report was returned to depuy synthes for evaluation.Visual examination of the device confirmed that stem is separated by half.The femoral head was still engaged to the stem.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4) pcs.2) date of manufacture: 08/25/2009.3) any anomalies or deviations identified in dhr: none.4) expiry date: 08/2019.Device history review: a manufacturing record evaluation was performed for the finished device (155402000/d29l71000) product and lot numbers, and no non-conformances were identified.

• 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16459187
• Report Number: 1818910-2023-04740
• Device Sequence Number: 6573062
• 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 Implanted Year: 2010
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/01/2023

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: D29L71000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 03/03/2023; 04/05/2023; 04/27/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/09/2023; 04/07/2023; 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2009
• 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: AML 10.5 STD 6.3 5/8 STD 12/14; DURALOC 1200 SERIES 58MM OD; ENDURON 10D 58 OR 70ODX32ID; HIP BALL BIOLOX 32 +9 12/14
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male