MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML 12.0 MMA 6.3 5/8 STD 12/14; HIP FEMORAL STEM/SLEEVE

Catalog Number	155703000
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Corroded (1131); Degraded (1153); Osseointegration Problem (3003); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Abscess (1690); Cellulitis (1768); Foreign Body Reaction (1868); Hematoma (1884); Pain (1994); Tissue Damage (2104); Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	12/16/2015
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 received.Litigation alleges pain and metal poisoning.Update jul 05, 2017: medical records received.After review of the medical records for the mdr reportability, patient was revised to address metallosis and pseudotumor.Revision notes noted an osteolytic material, and there was corrosion of the taper.It was also stated in the operative notes that they encountered a large anterior based pseudotumor.Ct scan showed a fluid collection likely related to a large hematoma and a right anterolateral white blood cell localization concerning for cellulitis and abscess.Laboratory results for metal ions were above 7ppb.The stem is now being added for the reported elevated ions and corrosion.Product codes and lot numbers were updated.This complaint was updated on jul 20, 2017.
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).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 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).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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
Complaint description: litigation received.Litigation alleges pain and metal poisoning.Update jul 05, 2017: medical records received.After review of the medical records for the mdr reportability, patient was revised to address metallosis and pseudotumor.Revision notes noted an osteolytic material, and there was corrosion of the taper.It was also stated in the operative notes that they encountered a large anterior based pseudotumor.Ct scan showed a fluid collection likely related to a large hematoma and a right anterolateral white blood cell localization concerning for cellulitis and abscess.Laboratory results for metal ions were above 7ppb.The stem is now being added for the reported elevated ions and corrosion.Product codes and lot numbers were updated.This complaint was updated on jul 20, 2017.
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 caused or contributed to the potential event described in this report.
Event or Problem Description
Ppf alleges metal wear and loosening of stem.

• Brand Name: AML 12.0 MMA 6.3 5/8 STD 12/14
• Common Device Name: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 7000 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6757585
• Report Number: 1818910-2017-22030
• Device Sequence Number: 878310
• Product Code: LPH
• UDI-Device Identifier: 10603295059240
• UDI-Public: 10603295059240
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K953694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/05/2017

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 Expiration Date: 02/18/2007
• Device Catalogue Number: 155703000
• Device Lot Number: WF4LS1011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 06/27/2018; 09/05/2019; 11/28/2019
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 07/27/2018; 09/12/2019; 12/13/2019
• 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: 51 YR
• Patient Weight: 95