MAUDE Adverse Event Report: ENCORE MEDICAL L. P. SL-PLUS AND SLR-PLUS HIP; 32MM FEMORAL HEAD, +10MM

Model Number	402-32-010
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to a zimmer acebabular cup and liner in patient, an exacteeh stem and a djo chrome 3z +10.5 femoral head in patient.The reason for revision was eccentric wear of poly insert.Surgeon removed the head and tried a ceramic delta options 32mm head with +7mm neck.Stems trunim was very worn and would not grip new neck and head.Old 32mm +10.5 head was re-implanted on f.Trunim and zimmer poly was changed.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to a zimmer acetabular cup and liner in patient, an exactech stem and a djo chrome sz +10.5 femoral head in patient.The reason for revision was eccentric wear of poly insert.We removed our head and tried a ceramic delta options 32mm head with +7mm neck.Stems trunnion was very worn and would not grip new neck and head.Old 32mm +10.5 head was re-implanted on it.Trunnion and zimmer poly were changed.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was reported as eccentric wear of poly insert.The previous surgery and the surgery detailed in thisevent occurred 7.4 years apart.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 device was disposed of at hospital and not made available to djo surgical for examination.A review of the device history record (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device 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 eccentric wear of poly insert.There were no findings during this evaluation that indicate the reported device was defective.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the event.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

• Brand Name: SL-PLUS AND SLR-PLUS HIP
• Common Device Name: 32MM FEMORAL HEAD, +10MM
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 11796445
• Report Number: 1644408-2021-00430
• Device Sequence Number: 17110862
• Product Code: JDI
• UDI-Device Identifier: 00888912076555
• UDI-Public: (01)00888912076555
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2021

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 Expiration Date: 03/28/2017
• Device Model Number: 402-32-010
• Device Catalogue Number: 402-32-010
• Device Lot Number: 238G1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/28/2021; 06/28/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/17/2021; 06/28/2021
• 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: 79 YR