DJO SURGICAL 506-00-007Recalls & reported problems
Encore Medical, L.P. · STEM, HUMERAL SIZE7 RSP · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912143844), received between Dec 22, 2016 and Dec 5, 2024 — classified as 5 injuries.
The most frequently reported specific device problem is “Unstable” (2 reports).
4 other recalls cover devices cleared under the same FDA submission (K041066); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Unstable2
- Appropriate Device Problem Term/Code Not Available1
- Loose or Intermittent Connection1
Patient problems
- Joint Laxity2
- No Code Available2
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 20, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryAug 18, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD A LOOSE IMPLANT LIKELY FROM A FALL AT NURSING HOME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10420296 ↗InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 7413679 ↗InjuryDec 22, 2016Unstable
REVISION SURGERY - THE PATIENT'S ORIGINAL SURGERY ((B)(6)) TOOK PLACE ON (B)(6) 2014. ANOTHER ((B)(6)) TOOK PLACE ON (B)(6) 2014. ANOTHER REVISION ((B)(6)) TOOK PLACE ON (B)(6) 2015. THE LAST SURGERY TOOK PLACE ON (B)(6) 2016. ALL REVISIONS TOOK PLACE BECAUSE THE PATIENT WAS UNSTABLE AND THE SURGEON KEPT INCREASING THE GLENOID SIZE IN ORDER TO TRY TO MAKE THE JOINT STABLE. HE WAS UNSUCCESSFUL, THUS REMOVING ALL DJO IMPLANTS, ACCORDING TO THE REPRESENTATIVE.
Patient problems: No Code Available
MAUDE report 6201577 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K041066. One submission often covers many models, so check the product and lot details in each record.
- Z-0098-2024 · Aug 22, 2023 · Open, ClassifiedREVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
- Z-0185-2008 · Aug 8, 2007 · TerminatedEncore Reverse Shoulder Prosthesis (RSP) System, Standard Size 40 RSP Humeral Socket Insert; Catalog #: 508-00-040; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 7875
- Z-0184-2008 · Aug 8, 2007 · TerminatedEncore Reverse Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket Insert; Catalog #: 508-00-036; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 7875
- Z-1566-05 · Jul 28, 2005 · TerminatedEncore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page