MAUDE Adverse Event Report: ENCORE MEDICAL L.P. CLP HIP; HIP, STEM, CLP, LATERAL OFFSET, SIZE#6, IMPLANT, POLISHED NECK

Model Number	931-40-756
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - stem was put in too distal, leaving patient's leg significantly shorter than the other leg.Stem was removed and replaced with a modular stem from another vendor.Also, liner and head were replaced by another vendor as well.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as surgeon error.The previous surgery and the surgery detailed in this event occurred 4 years and 5 months 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 device history records (dhr) shows that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was a nonconformance associated with the main part # 931-40-756, liner/non-hooded-neu, mp9, hxe-plus, 40mm which documents that out of (b)(4) parts lot 1 part was rejected and scrapped.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 surgeon error.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.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 if it becomes available.
Additional Manufacturer Narrative
Manufacture narrative: the reason for this revision surgery was reported as surgeon error.The previous surgery and the surgery detailed in this event occurred 4 years and 5 months 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 device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports (ncmr) associated with the main part.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 surgeon error.There were no findings during this evaluation that indicate thereported 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.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 if it becomes available.

• Brand Name: CLP HIP
• Common Device Name: HIP, STEM, CLP, LATERAL OFFSET, SIZE#6, IMPLANT, POLISHED NECK
• 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: kiersten soderman ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 13161487
• Report Number: 1644408-2021-01537
• Device Sequence Number: 14447891
• Product Code: KWA
• UDI-Device Identifier: 00888912099783
• UDI-Public: (01)00888912099783
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022
• 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: 06/22/2022
• Device Model Number: 931-40-756
• Device Catalogue Number: 426-11-060
• Device Lot Number: 418N1014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2016
• 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 870B1072.; 400-03-401 LOT 870B1072.; 426-11-060 LOT 418N1014.; 931-40-756 LOT 763N1942.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male