MAUDE Adverse Event Report: ENCORE MEDICAL L.P STEM, HUMERAL; STEM, HUMERAL, PLASMA W/MALE TAPER, 10

Model Number	503-00-010
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This evaluation is limited in scope as the items associated with this investigation were not returned to djo surgical - (b)(4) for examination.The surgery was completed as intended and without incident.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There were no findings during this evaluation that indicate the reported devices were defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.The root cause of this complaint was a revision surgery due to over stuffing in joint.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.Inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The revision surgery was completed successfully.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 a nonconformance associated with the concomitant part #500-02-154, glenoid, keeled 54mm cm foundation shoulder which documents that out of 30 parts lot, 4 parts were rejected and scrapped due to machine marks.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.(aravindraj).
Event or Problem Description
Revision surgery - over stuffing in joint.The previous surgery and the surgery detailed in this event occurred 10 years and 7 months apart.

• Brand Name: STEM, HUMERAL
• Common Device Name: STEM, HUMERAL, PLASMA W/MALE TAPER, 10
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 12617867
• Report Number: 1644408-2021-01090
• Device Sequence Number: 1479376
• Product Code: KWS
• UDI-Device Identifier: 00888912024334
• UDI-Public: (01)00888912024334
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K950651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: 503-00-010
• Device Catalogue Number: 503-00-010
• Device Lot Number: 764C1005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 10/12/2021
• 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: Required Intervention
• Patient Age: 79 YR