MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AML LG STATURE 12.0MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155402120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Weakness (2145); Discomfort (2330); Injury (2348); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671)
Date of Event	04/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 broken aml stem and loosening at the bone to implant interface.It was also indicated that the stem fractured and a new stem and head were implanted.A new poly was inserted as well.Doi: unknown; dor: (b)(6) 2018; left hip.
Additional Manufacturer Narrative
Pc-(b)(4).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.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).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
Update ad 24 jan 2019.Pinnacle litigation records received.Litigation alleges that the patient experienced pain, weakness, discomfort, suffering, popping in her left femur, periprosthetic femur fracture, injury, partial or complete loss of mobility and loss of range of motion.The patient previously had a head and liner revision under (b)(4).The stem was not revised at that time.Part and lot numbers for the stem were available on (b)(4).Added lawyer and law firm, additional patient codes, doi, corrected part number for the stem and added lot number for the stem.Doi: (b)(6) 2013 - dor: (b)(6) 2018 (left hip).This complaint was updated on 04 feb 2019.
Additional Manufacturer Narrative
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.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 = > cw4a61000.Device history review = > no deviations or anomalies were found.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.

• Brand Name: AML LG STATURE 12.0MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7673185
• Report Number: 1818910-2018-64066
• Device Sequence Number: 59556
• Product Code: JDI
• UDI-Device Identifier: 10603295058359
• UDI-Public: 10603295058359
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/26/2018

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 Catalogue Number: 155402120
• Device Lot Number: CW4A61000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 08/14/2018; 01/24/2019; 07/26/2019
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 08/31/2018; 02/05/2019; 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention