MAUDE Adverse Event Report: ENCORE MEDICAL L.P BIOLOX DELTA HIP; HEAD, FEMORAL, CERAMIC, BILOX DELTA, 40MM -4.0

Model Number	932-40-756
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 has persistent pain after primary hip reconstruction.Surgeon decided to take the patient back and revise the acetabular.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was reported as pain.The previous surgery and the surgery detailed in this event occurred 4 months, 3 weeks 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 devices were disposed of at hospital and not made available to djo surgical for examination.A review of the incident ceramic head's device history records (dhr) show that the implant met design and manufacturing requirements when released for use from djo.Additionally, the vendor from whom djo purchases was these semi-produced ceramic heads was asked to conduct a document review of the ceramic head's initial production at their site, and they confirmed this implant's certificate of conformance to all material properties, with no indications of a pre-existing material defect; ceramtec's document review is attached to this complaint.There were no nonconforming material reports associated with the production of this part's production lot at djo that may have contributed to the reported event.Customer complaint history of the reported device showed no present trends or on-going issues that need review.There have been no complaints filed against other devices from this implant's production lot at djo.Since there are 52 complaints have been filed that report revision surgeries for pain in hip systems using djo's ceramic heads, which represents a 0.118% complaint rate for this failure mode, which is well below industry standard.Possible sources of the patient's pain include inadequate soft tissue support, poor patient bone density, patient bone deterioration, excessive range of motion, patient activities, or trauma.Another potential source of pain: since one of the replacement screws (25mm) was shorter than the original screws (30mm), it's possible that the pain was caused by one of the original screws being too long, making contact with sensitive soft tissue.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.Rma examination: the ceramic head was returned to djo for examination.The implant was returned with a coating of patient fluid/tissue on some of its surfaces, some of this was removed with alcohol and a swab to prepare the sphere for dimensional inspection.There are wearmarks inside the implant's taper that are consistent with assembly with the hip stem's taper.The articulating surface of the sphere has some staining from patient substance buildup, but there are no scratches, gouges, or dents.Photos of the returned implant are attached to this complaint.Re-inspection of the explant: the explanted ceramic head, upon returning to djo, was decontaminated, photographed, then brought to djo's quality control team for inspection.The head was inspected by cmm, measuring within tolerance for all critical dimensions on the part's engineering drawing.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: BIOLOX DELTA HIP
• Common Device Name: HEAD, FEMORAL, CERAMIC, BILOX DELTA, 40MM -4.0
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin,tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin,tx 78758-5445
• Manufacturer Contact: teffany hutto ; 9800 metric blvd; austin,tx 78758-5445
• MDR Report Key: 11225179
• Report Number: 1644408-2021-00006
• Device Sequence Number: 1675430
• Product Code: LZO
• UDI-Device Identifier: 00888912100335
• UDI-Public: (01)00888912100335
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K082844
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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
• Report Date (Section B): 01/13/2022
• 2 Devices were Involved in the Event: 1 2

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: 11/06/2023
• Device Model Number: 932-40-756
• Device Catalogue Number: 400-03-401
• Device Lot Number: 870B1111
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 01/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 400-03-401 LOT 870B1111; 932-40-756 LOT 815N2029; 400-03-401 LOT 870B1111
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male