MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. KERAMOS CERAMIC/CERAMIC HIP SYSTEM; LINER, CERAMIC ,AL-AL 32X56/58MM

Model Number 400-01-297

Device Problem Material Integrity Problem (2978)

Patient Problems Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530)

Event Date 03/03/2021

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Event Description

Revision surgery - keramos ceramic-on-ceramic bearing implanted.Revised for pain and suspected ceramic liner failure.During revision surgery, no liner was evident and extensive metallosis was noted.Cup was removed and replaced with competitive 60mm cup and liner.Djo 36mm delta option head and 7.0mm adaptive sleeve were utilized to replace the head.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was for pain and suspected ceramic liner failure.The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The healthcare professional indicated another suitable device was available for use.The revision surgery was completed as intended.This investigation is limited in scope as only partial information was provided to djo surgical - austin for review.The revised item was not returned for examination and the item and or lot number was not provided.To adequately investigate this event, the part and or lot number are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported item showed no present trends or on-going issues that are needing a review.Given the limited information, a search for an invoice (of the previous surgery) produced no results, therefore; the item(s) removed could not be identified.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

• Brand Name: KERAMOS CERAMIC/CERAMIC HIP SYSTEM
• Type of Device: LINER, CERAMIC ,AL-AL 32X56/58MM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin, texas 78758-5445
• MDR Report Key: 11596353
• MDR Text Key: 243172082
• Report Number: 1644408-2021-00223
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00888912075749
• UDI-Public: (01)00888912075749
• Combination Product (y/n): N
• PMA/PMN Number: N980003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/22/2021

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 Model Number: 400-01-297
• Device Catalogue Number: 498-32-056
• Device Lot Number: UKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 05/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 400-01-297, LOT UNKNOWN; 498-01-056 LOT UNKNOWN; 498-01-056, LOT UNKNOWN; 498-32-056 LOT UNKNOWN; 498-01-056 LOT UNKNOWN; 498-32-056 LOT UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR