MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. METAL ON METAL HIP SYSTEM; LINER, METAL-METAL 34MM NEUTRAL MP7

Catalog Number	499-34-007
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/19/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to metal debris causing pain in the hip.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was a painful hip and metal debris.No information was provided about any patient activities, trauma or medical contraindications that may have contributed to the need for revision surgery.The revision surgery occurred after components were implanted for approximately 10 years, 5 months.According to the d-ticket for the revision surgery, a part number 400-04-360, delta ceramic head, 36mm and a part number 400-05-004 ceramic offset sleeve +4mm, were implanted.The complaint record indicates that the shell, liner, head and sleeve were removed.It is likely that the shell and liner were replaced with competitor parts.The complaint record indicates that the original stem remains in the patient.The surgery was completed as intended with no risk or adverse event.The event occurred when the agent was not present; the components were lost or disposed of.A review of the device history records (dhrs) revealed no non-conforming material reports (ncmr's) associated with any of the components listed in the complaint.The dhr evidence indicates that all critical dimensions and specifications were met when these products were released from (b)(4).The product complaint report history was reviewed; no adverse trends were identified.Sterilization records were reviewed.All components received proper sterilization at the time of release.The root cause for the pain and metal debris was not reported.This investigation is limited in scope because explanted products were not returned to (b)(4).Possible causes of pain and metal debris include trauma, osteolysis, and wear from impingement due to malpositioned components.A definitive root cause cannot be determined without further information such as patient x-rays.There was no information reported that evidences a material, design, or manufacturing problem with the product.

• Brand Name: METAL ON METAL HIP SYSTEM
• Common Device Name: LINER, METAL-METAL 34MM NEUTRAL MP7
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 5729332
• Report Number: 1644408-2016-00383
• Device Sequence Number: 813249
• Product Code: KWA
• UDI-Device Identifier: 00888912082389
• UDI-Public: (01)00888912082389
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K040354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2016

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: 07/31/2010
• Device Catalogue Number: 499-34-007
• Device Lot Number: 270702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2016
• Supplement Report FDA Received Date: 12/05/2016
• 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: 67 YR