MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 AML HIGH OFFSET LG STAT 13.5MM; AML IMPLANT : HIP FEMORAL STEM

Model Number	1554-03-135
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Synovitis (2094); Discomfort (2330); Injury (2348); Hypoesthesia (2352); Test Result (2695); Not Applicable (3189)
Date of Event	10/19/2018
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.
Event or Problem Description
Litigation alleged pain, discomfort, injury and elevated blood cobalt and chromium levels.
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.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
Pfs alleges numbness and soreness.Afte review of medical records, the patient was revised for failed metal on metal hip repalcement, bilateral hips.Operative notes reported that there were little more synovitis and more fluid on the right hip compared to the left hip.
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.  .
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.H10 additional narrative: corrected: h6.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, a follow-up medwatch will be filed as appropriate.
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 : null.Device history batch : null.Device history review : null.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. .
Event or Problem Description
Ppf alleges pseudotumor and metallosis.After review of medical records, patient was revised to address failed metal on metal hip replacements, bilateral hips.Revision note reported elevated cobalt chromium levels, moderate discomfort in the right and synovitis.

• Brand Name: AML HIGH OFFSET LG STAT 13.5MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8077838
• Report Number: 1818910-2018-75758
• Device Sequence Number: 16486582
• Product Code: JDI
• UDI-Device Identifier: 10603295058441
• UDI-Public: 10603295058441
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K012364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/16/2019

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 Model Number: 1554-03-135
• Device Catalogue Number: 155403135
• Device Lot Number: AR6HN1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 11/20/2018; 12/16/2019; 01/14/2020; 01/14/2020
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 11/21/2018; 12/27/2019; 01/20/2020; 01/23/2020
• 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: 64 YR
• Patient Weight: 87