MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 AML SM STATURE 13.5MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number	155401135
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Pain (1994); Distress (2329); Injury (2348); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)
Date of Event	07/19/2016
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.Concomitant medical products: articuleze m head 36mm +5; pinnacle mtl ins neut36idx50od; aml sm stature 13.5mm stem; unknown hip acetabular cup.
Event or Problem Description
Complaint description: patient was revised due to pain and dislocation.Update ad (b)(6) 2018 (b)(4) is reopened under (b)(4) due to receipt of pinnacle litigation records.In addition to what were previously alleged, litigation alleges injury, elevated blood metal levels, injuries that inhibit movement, emotional distress, and mental anguish.The lawyer, law firm and patient harm has been updated.The stem was included due to the alleged elevated blood metal levels.Doi: (b)(6) 2007; dor: (b)(6) 2016; left hip.
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.Product complaint # (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.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.
Event or Problem Description
Ppf alleges pseudotumor.
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. .

• Brand Name: AML SM STATURE 13.5MM
• 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: 7762286
• Report Number: 1818910-2018-66088
• Device Sequence Number: 11227781
• Product Code: JDI
• UDI-Device Identifier: 10603295058243
• UDI-Public: 10603295058243
• 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: 2007
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2018

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: 155401135
• Device Lot Number: BJ8AA1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 03/05/2019; 09/26/2019
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 03/13/2019; 10/14/2019
• 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
• Patient Age: 82 YR