MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR ACET DM, HEAD TRIAL, THREADED OFFSET SLEEVE, -3.5MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 803-15-111

Device Problem Material Integrity Problem (2978)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Instrument failure - 1 hour delay in surgery.

Manufacturer Narrative

The agent reported (surgeon had difficulty dislocating trial hip configuration.So, he used a bone saw and chisel to cut apart the head and sleeve trials.Rendering them completely useless for future cases.Female, 52).This investigation is limited in scope as only partial information was provided to djo surgical - austin for review.The revised item(s) was not returned for examination and the item and or lot number(s) was not provided.To adequately investigate this event, the part and lot number(s) are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported item(s) showed no present trends or on-going issues that are needing a review.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.

• Brand Name: EMPOWR ACET DM, HEAD TRIAL, THREADED OFFSET SLEEVE, -3.5MM
• Type of Device: 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: 17205817
• MDR Text Key: 317913856
• Report Number: 1644408-2023-00787
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00190446689775
• UDI-Public: 00190446689775
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 803-15-111
• Device Catalogue Number: 803-15-111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 803-15-140.
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female