MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML SM STATURE 10.5MM; HIP FEMORAL STEM/SLEEVE

Model Number	1554-01-105
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Bone Fracture(s) (1870); Unspecified Infection (1930); Muscular Rigidity (1968); Necrosis (1971); Pain (1994)
Date of Event	11/06/2014
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
Litigation alleges patient was revised due to pain, metallosis and avascular necrosis.Update jul 12, 2017: legal medical records received.In addition to what was previously alleged, pfs alleges loss of balance, difficulty sitting/standing, stiffness, and high levels of cobalt-chromium.After review of the medical records for mdr reportability, it was stated that the patient was revised due to infected left tha.Revision note stated gross pus, chronic non-displaced fracture of the greater trochanter.Laboratory values for cobalt-chromium showed above 7ppb.Cup, two screws, stem, and hole eliminator were added due to the reported infection.Part and lot information were provided.This complaint was updated on: aug 7, 2017.
Additional Manufacturer 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 = > 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.
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.  udi: (b)(4).

• Brand Name: AML SM STATURE 10.5MM
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6785039
• Report Number: 1818910-2017-22584
• Device Sequence Number: 1540807
• Product Code: JDI
• UDI-Device Identifier: 10603295058205
• UDI-Public: 10603295058205
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2017

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 Model Number: 1554-01-105
• Device Catalogue Number: 155401105
• Device Lot Number: Y88F61000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 02/19/2019; 03/05/2021
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 02/28/2019; 03/08/2021
• 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: 59 YR
• Patient Weight: 66