DELTA XTEND
Received Jun 8, 2026 · Event occurred May 13, 2026
Report 1818910-2026-09826 · MDR key 25433361
Device
Generic name
Delta Xtend Implants : Shoulder Humeral Cup
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
130742106
Lot number
5817146
Product problems
- Naturally Worn
Patient
71 YR · Male
- Unspecified Musculoskeletal problem
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A RECORDS EVALUATION (MRE) WAS NOT PERFORMED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: THERE IS NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.
Description of Event or Problem
IT WAS REPORTED THAT PATIENT HAS HAD MULTIPLE FALLS AND THE GLENOSPHERE DISASSOCIATED FROM THE BASE PLATE. POLY WAS DEFORMED FROM RUBBING AGAINST BASEPLATE. DOCTOR DECIDED THAT A CTA HEAD WOULD BE THE BEST CHOICE FOR THIS PATIENT. TOOK OUT POLY, GLENOSPHERE, BASEPLATE, AND SCREWS AND REPLACED WITH THE CTA HEAD. IT WAS STATED THAT THE LOOSENING OF SHOULDER GLENOSPHERE WAS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.