MAUDE Adverse Event Report: ENCORE MEDICAL L.P. TAPERFILL HIP; TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 10

Model Number	425-97-010
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
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
Reported incident - when the surgeon pulled the stem out of the sterile package, a very small blue, unidentified object was embedded in the porous coating of the stem.After several tries, he was finally able to remove the object with a small needle nosed kocher.He instructed the scrub tech to remove the object off of the field immediately.Scrub tech was able to recover the object and have it saved in a specimen container.
Additional Manufacturer Narrative
The reason for this complaint was reported as the piece of a personnel's glove attaching onto the porous coating during the sterilization packaging.The healthcare professional indicated this event occurred during surgery, near the patient.There was a one (1) to two (2) minute delay in surgery but the 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 reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are needing a review.One (1) part from this lot was located within inventory and reviewed for similar defects.Defects were not present on the part.The root cause of this complaint is likely attributed to a piece of a personnel's glove attaching onto the porous coating during the sterilization packaging.There is no risk to the patient as the object is easily recognized when removing the device from packaging.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The surgery was completed successfully.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: TAPERFILL HIP
• Common Device Name: TAPERFILL HIP STEM, LATERAL OFFSET, SIZE 10
• 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: 12853473
• Report Number: 1644408-2021-01305
• Device Sequence Number: 4292984
• Product Code: LPH
• UDI-Device Identifier: 00888912078689
• UDI-Public: (01)00888912078689
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 01/28/2022

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 Model Number: 425-97-010
• Device Catalogue Number: 425-97-010
• Device Lot Number: 175R2236
• 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: 10/25/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male