MAUDE Adverse Event Report: ENCORE MEDICAL L.P. LINEAR HIP; LINEAR, LATERAL, REDUCED NECK, SZ 8, W.P2 COATING

Model Number	425-99-008
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2020
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
Complaint - surgeon says this implant is off by at least 1 cm compared to the broach.Two additional broach trays were opened to make sure it wasn't the current broach.There is not visual difference.The next case also used an 8 lateral stem and everything is fine.The surgeon wanted this documented and for someone on the hip team to be notified.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as unknown.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 hip stem met design and manufacturing requirements when released for use.There were no non-conforming material reports(ncmr) associated with the production of this lot that may have contributed to the reported event.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 cannot be identified with certainty, because the incident broach and hip stem were not returned to djo for examination.A possible root cause of this complaint is surgical technique: ineffective broaching technique, either broaching too aggressively (stem will subside) or broaching too gently (stem will sit proud), can result in a stem not seating in its target location within the bone.It's also possible that the patient from this case had questionable bone integrity, with hardened bone or soft bone tissue both capable of resulting in difficulty seating implants correctly.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 if it becomes available.
Additional Manufacturer Narrative
The reason for this complaint was reported as unknown.The event occurred during surgery, near the patient.The agent was present and was able to find a suitable replacement device.There is a delay in surgery of 4 minutes.No adverse event, patient risk, or negative outcome due to the incident were reported.The incident device was not returned to djo for examination.A review of the device history record (dhr) shows that the hip stem met design and manufacturing requirements when released for use.There were no non-conforming material reports(ncmr) associated with the production of this lot that may have contributed to the reported event.No complaints have been filed against any other parts from this lot.Three similar complaints have been filed with that allege similar circumstances: in two complaints stems sat proud after broaching, while in another circumstance a stem subsided after broaching.These complaints are not indicative of a dimensional concern between broach sizes and stem sizes.The root cause of this complaint cannot be identified with certainty, because the incident broach and hip stem were not returned to djo for examination.A possible root cause of this complaint is surgical technique: ineffective broaching technique, either broaching too aggressively (stem will subside) or broaching too gently (stem will sit proud), can result in a stem not seating in its target location within the bone.It's also possible that the patient from this case had questionable bone integrity, with hardened bone or soft bone tissue both capable of resulting in difficulty seating implants correctly.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 if it becomes available.

• Brand Name: LINEAR HIP
• Common Device Name: LINEAR, LATERAL, REDUCED NECK, SZ 8, W.P2 COATING
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 10431333
• Report Number: 1644408-2020-00664
• Device Sequence Number: 11360721
• Product Code: LPH
• UDI-Device Identifier: 00888912078948
• UDI-Public: (01)00888912078948
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 02/01/2021

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: 12/26/2024
• Device Model Number: 425-99-008
• Device Catalogue Number: 425-99-008
• Device Lot Number: 573G1053
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 11/16/2020; 11/16/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 12/15/2020; 02/01/2021
• 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: Other
• Patient Age: 67 YR