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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. ALTIVATE REVERSE SHOULDER; ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 8X108MM

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ENCORE MEDICAL L.P. ALTIVATE REVERSE SHOULDER; ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 8X108MM Back to Search Results
Model Number 533-08-108
Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 03/11/2022
Event Type  Injury  
Event Description
Revision surgery: the patient had a loose humeral stem and the surgeon removed the current stem and replaced with a new one with a cement plug and cement.
 
Manufacturer Narrative
The reason for this revision surgery was reported as loosening.The previous surgery and the surgery detailed in this event occurred 1 month and 3 weeks 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 was an ncmr# (b)(4) associated with the main part #533-08-108, altivate reverse, humeral stem, small shell, sz8x108mm which document that out of 15 parts lot all the parts were rejected due to uneven polish in flute regions, and grain growth in polished area.Later, the rejected parts were reworked and accepted after proper justification.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 loosening.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.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.
 
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Brand Name
ALTIVATE REVERSE SHOULDER
Type of Device
ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 8X108MM
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 Key13956055
MDR Text Key288271026
Report Number1644408-2022-00393
Device Sequence Number1
Product Code KWS
UDI-Device Identifier00190446259121
UDI-Public(01)00190446259121
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172351
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/30/2022
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
Device Operator Health Professional
Device Model Number533-08-108
Device Catalogue Number533-08-108
Device Lot Number926W1564
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/14/2022
Initial Date FDA Received03/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
509-02-040 LOT 959W1049
Patient Outcome(s) Required Intervention;
Patient Age57 YR
Patient SexFemale
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