IMP,TSV,3.7,10,MTX,MG
Report
- Report Number
- 0002023141-2022-03028
- Event Type
- Injury
- Date Received
- December 6, 2022
- Report Date
- March 22, 2023
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019928
- PMA / PMN Number
- K101977
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0002023141-2022-03026. ZIMMER BIOMET COMPLAINT NUMBER :( B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0002023141-2022-03026-1. THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. ONE (1) IMP, TSV, 3.7, 10, MTX, MG (B)(6) & ONE (1) IMP, TSV, 3.7, 10, MTX, MG (B)(6) WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE. NO DAMAGE IDENTIFIED OR SIGNS OF MALFUNCTION THAT WOULD CONTRIBUTE TO THE EVENT. MEASUREMENTS MATCH DRAWING. BASED ON THE EVALUATION AND DIMENSIONAL ANALYSIS, DEVICE MALFUNCTION HAS NOT OCCURRED. ADDITIONALLY, THERE IS NO EXISTING NONCONFORMANCE / CAPA / HHE/D / IE / PRODUCT HOLD AGAINST THE REPORTED DEVICES THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ADVERSE EVENTS OR ACTIONABLE TRENDS FOR THE REPORTED EVENT OR DEVICES. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS WITHIN SPECIFICATIONS AND CONFORMING WHEN IT LEFT ZIMVIE. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBERS (1257851 & 1256675). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. LOT NUMBERS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. STERILIZATION RECORDS (OP#150) WERE REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBERS (1257851 & 1256675) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THE DEVICES COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED FAILURE (PAIN). THE REPORTED EVENT COULD NOT BE RECREATED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. HOWEVER, BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE MOST LIKELY CAUSE DETERMINED FROM THE INVESTIGATION IS DUE TO MISSING OR CONFUSING INSTRUCTIONS FOR USE, MATERIAL SELECTION. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #22 & #27 WERE MOBILE AND WERE REMOVED DUE TO PAIN & SWELLING. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1741575 | IMP,TSV,3.7,10,MTX,MG | DENTAL IMPLANT | DZE | ZIMMER DENTAL | TSVTB10 | 1256675 | 00889024019928 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female | Required Intervention |