DJO SURGICAL
Received Jul 2, 2026 · Event occurred Jun 10, 2026
Report 1644408-2026-01276 · MDR key 25699918
Device
Generic name
Silicone Ii Mcp Implant Size 50 (sterile Packed)
Manufacturer
Encore Medical L.p.Catalog number
MCP-50
Lot number
UNKNOWN
Product problems
- Patient Device Interaction Problem
Patient
82 YR · Female
- Failure of Implant
- Joint Laxity
Narrative
Additional Manufacturer Narrative
THE AGENT REPORTED: "IMPLANT WAS IN THREE PIECES. JOINT UNSTABLE. FEMALE 82." THE ACTUAL LENGTH OF IN-VIVO FOR THE ITEMS LISTED IS UNKNOWN AS THE ORIGINAL SURGERY DATE WAS NOT PROVIDED OR COULD BE ESTABLISHED. ITEM NUMBER: MCP-50. ITEM DESCRIPTION: EMPOWR ACET SYSTEM, CUP, HEMISPHERICAL, CLUSTER HOLE, 52MM. LOT#: UNKNOWN. PART REVISION: NA. PRODUCT TYPE: HAND. MANUFACTURE DATE: UNKNOWN. EXPIRATION DATE: UNKNOWN. THIS EVALUATION IS LIMITED IN SCOPE AS THE ITEM(S) ASSOCIATED WITH THIS INVESTIGATION WAS NOT RETURNED TO DJO SURGICAL - AUSTIN FOR EXAMINATION. THE SURGERY WAS COMPLETED AS INTENDED. 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 THAT THE REPORTED DEVICE(S) WAS DEFECTIVE. THE SURGEON PERFORMED THIS PROCEDURE TO REMEDY THE PATIENT'S CONDITION. NO FURTHER ACTION IS DEEMED NECESSARY. ROOT CAUSE: THE ROOT CAUSE OF THIS COMPLAINT WAS A REVISION SURGERY DUE TO FRACTURED MCP SILICONE IMPLANT RESULTING IN JOINT INSTABILITY. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN EVENT THAT ARE OUTSIDE OF THE CONTROL OF ENOVIS SURGICAL. CONTAINMENT: 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. DEVICE HISTORY RECORDS REVIEW: GIVEN THE LIMITED INFORMATION, AN EXTENSIVE SEARCH OF DJO RECORDS FOR AN INVOICE OF THE PREVIOUS SURGERY PRODUCED NO RESULTS, THEREFORE, WITHOUT THE RECORDS THIS INVESTIGATION CANNOT LEAD TO A FIRM CONCLUSION. COMPLAINT HISTORY: CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICE(S) SHOWED NO PRESENT TRENDS OR ONGOING ISSUES THAT NEED REVIEW.
Description of Event or Problem
REVISION SURGERY - DUE TO IMPLANT WAS IN THREE PIECES. JOINT UNSTABLE.