MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. SL-PLUS AND SLR-PLUS; HEAD, FEMORAL , COCR 28MM NEUTRAL

Model Number	497-28-000
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as dislocation.The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established.The healthcare professional indicated that there was a serious risk to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.This investigation is limited in scope as only partial information was provided to djo surgical.The revised items were not returned for examination and the items & lot number were not provided.To adequately investigate this event, the part and lot numbers are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to dislocation.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 surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Revision surgery - patient presented at the hospital with a dislocated hip.Unfortunately we do not have any patient records for the patient as their hip was done over 20 years ago.Patient only knew that surgeon had done his hip replacement surgery.They didn't know when it was done so tracking implants was impossible surgeon elected to remove the djo cup and liner and replace with another company product.We replaced the 28mm head with a new djo 28mm head.

• Brand Name: SL-PLUS AND SLR-PLUS
• Common Device Name: HEAD, FEMORAL , COCR 28MM NEUTRAL
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin texas 78758-5445
• MDR Report Key: 11575346
• Report Number: 1644408-2021-00184
• Device Sequence Number: 11850165
• Product Code: JDI
• UDI-Device Identifier: 00888912087254
• UDI-Public: (01)00888912087254
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K932481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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
• Operator of Device: Health Professional
• Device Model Number: 497-28-000
• Device Catalogue Number: 497-28-000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK-SURG LOT UNKNOWN; UNK-SURG LOT UNKNOWN
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 75 YR