MAUDE Adverse Event Report: ENCORE MEDICAL L.P BIPOLAR HIP; SHELL, BIPOLAR, MODULAR, ENCORE, SIZE51

Model Number	412-02-051
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as dislocation.The previous surgery and the surgery detailed in this event occurred 2 months and 1 week 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 returned to manufacturer and the evaluation anticipated but not yet begun at djo surgical.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was an ncmr#(b)(4) associated with the main part #412-02-051, shell, bipolar, modular, encore, size51 which document that out of 20 parts lot 1 part was rejected due to multiple dings on the rim.Later, the rejected part was used as is after proper justification.All other items in the lot were met with fit, form and function requirements.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed not 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 were no findings during this evaluation that indicate the reported devices were 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 also contribute to an event that are outside the control of djo surgical such as poor bone density, inadequate soft tissue support, patient activities or trauma.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.
Event or Problem Description
Revision surgery : due to bipolar shell came apart, patient went to emergency room because of dislocation.Surgeon tried reducing and pulled really hard resulting in 28m head pulling out of shell.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was reported as to dislocation.The previous surgery and the surgery detailed in this event occurred 2 months and 1 week apart.The healthcare professional indicated the items associated with this investigation were returned to djo surgical for examination and it was found that the shell, bipolar modular, encore, size51 is warped and outside of the acceptable dimensions.Dimensional review showed that for 412-02-051, the following features were out of dimension: ø.1.040 ±.003, ø'a' 1.673 ±.003, ø'e' 1.617 ±.002, and.125 ±.005.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was an ncmr#60328 associated with the main part #412-02-051, shell, bipolar, modular, encore, size51 which document that out of (b)(4) parts lot 1 part was rejected due to multiple dings on the rim.Later, the rejected part was used as is after proper justification.All other items in the lot were met with fit, form and function requirements.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices 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.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 also contribute to an event that are outside the control of djo surgical such as poor bone density, inadequate soft tissue support, patient activities or trauma.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: BIPOLAR HIP
• Common Device Name: SHELL, BIPOLAR, MODULAR, ENCORE, SIZE51
• 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: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 13793688
• Report Number: 1644408-2022-00338
• Device Sequence Number: 16585730
• Product Code: KWY
• UDI-Device Identifier: 00888912077422
• UDI-Public: (01)00888912077422
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K953510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 06/13/2022

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: 07/19/2026
• Device Model Number: 412-02-051
• Device Catalogue Number: 412-02-051
• Device Lot Number: 999B1120
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2021
• 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: 497-28-035 LOT 631C1401
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male