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

Model Number	1557-02-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); Insufficient Information (4580)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Aml femoral stem was broken and needed to be revised and replaced with a different stem.
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.Corrected: b3, h6 health effect - clinical code.
Event or Problem Description
The additional information received.A.Please confirm when has the event occurred? right before the revision surgery as it was the reason for revision surgery.B.Can you please provide valid lot number of aml 10.5 mma 6.3 5/8 std 12/14 (155702000)? you have all the labels at the picture i enclosed.C.Was the revision surgery performed? if yes, please provide the date of revision.Yes, 8th april 2022 d.Was there a surgical delay because of this event? if yes, what was the duration of the delay? the whole revision surgery was because of this event.If this didn¿t happen, no surgery would be needed.E.What is the affected side involved in this event? left.F.Was there any patient harm or adverse symptoms that the patient experienced that led to revision? it was not possible to walk with this broken implant.
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.Visual examination of the device confirmed the fracture condition.The femoral hip stem was fractured through distal neck of the stem through the superior insertion feature and extraction hole, distal and parallel to the collar.Depuy synthese considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 10.5 MMA 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: 14307594
• Report Number: 1818910-2022-08325
• Device Sequence Number: 12005875
• Product Code: LPH
• UDI-Device Identifier: 10603295059233
• UDI-Public: 10603295059233
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K953694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1998
• Device Explanted Year: 2022
• 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): 05/05/2022

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: 1557-02-000
• Device Catalogue Number: 155702000
• Device Lot Number: LRW-03
• 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: 04/21/2022
• Supplement Date Received by Manufacturer: 05/31/2022; 06/07/2022; 07/25/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/01/2022; 06/09/2022; 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 88 KG