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

Model Number	1554-02-135
Medical Device Problem Codes	Biocompatibility (2886); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
Date of Event	07/26/2013
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.Occupation: attorney.(b)(4).
Event or Problem Description
Litigation alleges that the patient suffers from pain.Update ad 21 aug 2018: (b)(4) has been reopened under (b)(4) due to receipt of ppf and sticker sheets record.In addition to previous allegation, ppf alleges elevated metal ions.Stem was added due to alleged elevated metal ions.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
Pfs alleges lack of mobility, lack of full range of motion, metallosis and emotional distress.After review of medical records patient was revised to addressed femoral stem loosening.Doi: (b)(6) 2009; dor: (b)(6) 2013; left hip.(b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Additional narrative: 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 will be filed as appropriate.
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 heen able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not bsynthes 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.Additional narrative: 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AML LG STATURE 13.5MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8687773
• Report Number: 1818910-2019-95711
• Device Sequence Number: 11518098
• Product Code: JDI
• UDI-Device Identifier: 10603295058366
• UDI-Public: 10603295058366
• Combination Product (Y/N): N
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/20/2019

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 Expiration Date: 03/31/2018
• Device Model Number: 1554-02-135
• Device Catalogue Number: 155402135
• Device Lot Number: CH2AR1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 11/18/2019; 12/05/2019; 02/05/2020
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 11/26/2019; 12/10/2019; 02/06/2020
• 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
• Patient Age: 62 YR