POROUS TITANIUM GLENOID POST REGENEREX
Report
- Report Number
- 0001825034-2022-01970
- Event Type
- Injury
- Date Received
- August 29, 2022
- Date of Event
- August 6, 2020
- Report Date
- May 14, 2024
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- MBF
- UDI-DI
- 00880304459854
- PMA / PMN Number
- K193038
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01971, 0001825034-2022-01972, 0001825034-2022-01973, 0001825034-2022-01974. MEDICAL PRODUCTS: ITEM#: 113952, SM HYBRID GLENOID BASE 4 MM; LOT#: 165380. ITEM#: 113611, COMP PRIMARY STEM 11 MM MICRO, LOT#: 821310. ITEM#: 113032, VERSA-DIAL 42X18X46 HUM HEAD; LOT#: 306460. ITEM#: 118001, VERSA-DIAL/COMP TI STD TAPER; LOT#: 926330. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01971-2, 0001825034-2022-01973-2. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2; H3; H6. THE ROTATOR CUFF IS A GROUP OF MUSCLES AND TENDONS THAT SURROUND THE SHOULDER JOINT, KEEPING THE HEAD OF THE HUMERUS FIRMLY WITHIN THE SHALLOW SOCKET OF THE SHOULDER. ROTATOR CUFF INJURIES OCCUR MOST OFTEN IN PEOPLE WHO REPEATEDLY PERFORM OVERHEAD MOTIONS OR EXPERIENCE ANY SORT OF TRAUMA TO THE SHOULDER. DEGENERATIVE TEARS CAN ALSO OCCUR BECAUSE OF GRADUAL WEARING DOWN OF THE TENDON. THIS DEGENERATION NATURALLY OCCURS AS WE AGE. FACTORS THAT LEAD TO DEGENERATIVE TEARS INCLUDE REPETITIVE STRESS, LACK OF BLOOD SUPPLY, BONE SPURS, AND INCREASED AGE. COMMON SYMPTOMS OF A ROTATOR CUFF TEAR INCLUDE PAIN AT REST OR WITH ACTIVITY, WEAKNESS, AND CREPITUS. TYPICALLY, AN ANATOMIC SHOULDER IS PERFORMED WHEN THE ROTATOR CUFF IS STABLE AND INTACT, AND A REVERSE SHOULDER IS PERFORMED FOR AN INSUFFICIENT ROTATOR CUFF. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAD REVISION SURGERY APPROXIMATELY ONE (1) YEAR AND EIGHT (8) MONTHS AFTER THE INITIAL SURGERY DUE TO PAIN, LOSS OF RANGE OF MOTION, AND LOOSENING OF THE IMPLANTS.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANATOMICAL RIGHT SHOULDER REPLACEMENT APPROXIMATELY FIVE (5) YEARS AND THREE (3) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY THREE (3) YEARS AND SEVEN (7) MONTHS AGO DUE TO PAIN AND AN INSUFFICIENT ROTATOR CUFF. PRIOR TO THE SURGERY BEGINNING, THE PATIENT'S SHOULDER WAS EASILY DISLOCATED ANTERIORLY UPON EXAM BUT STABLE POSTERIORLY. THE SURGEON AT THAT TIME DECIDED TO CONVERT THE PATIENT'S SHOULDER TO A REVERSE DUE TO AN INSUFFICIENT ROTATOR CUFF. THE SURGEON LEFT THE STEM IMPLANT IMPLANTED, THE SURGERY WAS COMPLETED WITHOUT ANY COMPLICATIONS.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2100797 | POROUS TITANIUM GLENOID POST REGENEREX | SHOULDER PROSTHESIS, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED / EXTREMITIES | MBF | ZIMMER BIOMET, INC. | PT-113950 | 607920 | 00880304459854 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Hospitalization| R | SEE H10 NARRATIVE |