MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML SM STATURE 12.0MM; AML IMPLANT : HIP FEMORAL STEM

Catalog Number 155401120

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Distress (2329); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189)

Event Date 02/27/2018

Event Type  Injury  

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.

Event Description

Pinnacle litigation received.Litigation alleges friction and wear between the metal head and liner caused large amount of toxic metal ions to be released into the patient's body resulting to injury, inflammation, discomfort, pain including when ambulating or moving to and from a sitting position, loss of mobility, loss of range of motion, mental anguish, disfigurement, and emotional distress.Doi: (b)(6) 2008; dor: (b)(6) 2018; right hip.

Manufacturer Narrative

(b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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. udi: (b)(4).

• Brand Name: AML SM STATURE 12.0MM
• Type of Device: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7663778
• MDR Text Key: 113191186
• Report Number: 1818910-2018-63809
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K012364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 155401120
• Device Lot Number: B49CV1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 08/06/2018; 03/12/2019
• Supplement Dates FDA Received: 08/07/2018; 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR