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	Pain (1994)
Date of Event	06/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as pain.The actual length of in-vivo for the item(s) listed is unknown as the original surgery date was not provided or could be established.Initial or prolonged hospitalization was required.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The devices were disposed of at the hospital and not made available to djo surgical for examination.Customer complaint history of the reported item 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 pain.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.
Event or Problem Description
Revision surgery - patient complained of pain.

• 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, tx 78758-5445,
• MDR Report Key: 10307543
• Report Number: 1644408-2020-00582
• Device Sequence Number: 19038912
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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: 06/24/2020
• Initial Report FDA Received Date: 07/22/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR