MAUDE Adverse Event Report: ENCORE MEDICAL L.P TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 14; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	425-97-014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	06/29/2023
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
Primary surgery - loosening and dislocation.
Additional Manufacturer Narrative
The agent reported "(these implants were loose and the patient kept dislocating.Male 89 yrs)." the items were lost/discarded, therefore the reported problem could not be confirmed.This event occurred during surgery near the patient.The components were not inspected prior to surgery.There was another suitable device available, however, the incident did cause a 10 min.Delay in surgery.There was no risk or adverse event reported and the surgery was completed as intended.Surgical components condition can be determined while being used for its intended purpose.This does not indicate a product deficiency, failure, or issue.No further action is deemed necessary at this time.A review of the device history record(s) show that the reported components, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product(s) that may have contributed to the reported event.The device(s) was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.425-97-014 lot 179r2115-complaint database review showed no previous complaints, and this is the first complaint across all failure code categories.There are no indications that this item has a design or material deficiency.400-03-402 lot 871b1469-complaint database review showed no previous complaints, and this is the first complaint across all failure code categories.There are no indications that this item has a design or material deficiency.The root cause for this complaint is that the components were loose causing dislocation.There are multiple factors that are outside of the control of djo surgical that may contribute to an event.

• Brand Name: TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 14
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 17393603
• Report Number: 1644408-2023-00969
• Device Sequence Number: 8913676
• Product Code: LPH
• UDI-Device Identifier: 00888912078726
• UDI-Public: 00888912078726
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/29/2023

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 Catalogue Number: 425-97-014
• Device Lot Number: 179R2115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• 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: 400-03-402 LOT: 871B1469
• Outcome Attributed to Adverse Event: Other
• Patient Age: 89 YR
• Patient Sex: Male