IMP,TSV,6.0,11.5,MTX,MG
Report
- Report Number
- 0002023141-2022-03010
- Event Type
- Injury
- Date Received
- December 5, 2022
- Date of Event
- December 9, 2021
- Report Date
- January 27, 2023
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019881
- PMA / PMN Number
- K101977
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL PMA/510(K) NUMBER ¿K101880. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. D9: DEVICE AVAILABILITY WAS UPDATED TO NO. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: INVESTIGATION TYPE CODES WERE ADDED: 3331, 4109, 4110, 4111 AND 4114. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 4315. H10: NARRATIVE/DATA WAS UPDATED. ONE (1) IMP, TSV,6.0,10, MTX, MG ((B)(6)) WAS REPORTED TO CAUSE A REOCCURRING LESION / GRANULATED TISSUE MEDICAL EVENT; HOWEVER, THE PRODUCT WAS NOT RETURNED. BASED ON THE EVALUATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED. HOWEVER, THERE IS NO EXISTING NONCONFORMANCE / CAPA / HHE/D / IE / PRODUCT HOLD AGAINST THE REPORTED DEVICE THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ADVERSE TRENDS OR ACTIONABLE TRENDS FOR THE REPORTED EVENT OR DEVICES. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCTS WERE WITHIN SPECIFICATIONS AND CONFORMING WHEN THEY LEFT ZIMVIE. DHR REVIEW FOR THE LOT (1250935) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THEREFORE, THE REPORTED EVENT COULD NOT BE RECREATED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE MOST LIKELY CAUSES DETERMINED FROM THE INVESTIGATION ARE IMPLANT OF INAPPROPRIATE SIZE, CLINICIAN ERROR, AND PATIENT SPECIFIC ISSUES. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.
THIS REPORT IS BEING SUBMITTED TO RELAY A CORRECTION TO THE INITIAL SUBMISSION REPORT 0001038806-2020-0002023141-2022-03010 AND SUPPLEMENTAL SUBMISSION REPORT 0002023141-2022-03010-1. CORRECTION: THE CORRECT IMPLANT INFORMATION ASSOCIATED WITH THIS COMPLAINT IS (B)(4) ,LOT NUMBER 1243759. THE FOLLOWING SECTIONS ARE BEING REPORTED: H6: TYPE OF INVESTIGATION CODES WERE ADDED: 3331, 4109 AND 4110. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 4310. ONE (1) IMP,TSV,6.0,11.5,MTX,MG (TSVT6B11) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED NO MALFUNCTION. BASED ON THE EVALUATION, DEVICE MALFUNCTION HAS NOT OCCURRED. HOWEVER, THERE IS NO EXISTING NONCONFORMANCE / CAPA / HHE/D / IE / PRODUCT HOLD AGAINST THE REPORTED DEVICE THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ADVERSE TRENDS OR ACTIONABLE TRENDS FOR THE REPORTED EVENT OR DEVICE. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS WITHIN SPECIFICATIONS AND CONFORMING WHEN IT LEFT ZIMVIE. DHR REVIEW FOR THE LOT (1243759) REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. THE COMPLAINT IS NOT RELATED TO THE FUNCTIONAL PERFORMANCE OF THE DEVICE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THEREFORE, THE REPORTED EVENT COULD NOT BE RECREATED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE MOST LIKELY CAUSES DETERMINED FROM THE INVESTIGATION ARE IMPLANT OF INAPPROPRIATE SIZE, CLINICIAN ERROR, AND PATIENT SPECIFIC ISSUES. 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.
CUSTOMER REPORTED THAT THE PATIENT RETURNED FOR AN EVALUATION OF RECURRENT LESION/GRANULATED TISSUE AROUND THE IMPLANT AT TOOTH LOCATION #14. CURETTAGE OF THE GRANULATION TISSUE WAS PERFORMED, AND THE IMPLANT WAS REMOVED TO FACILITATE DEBRIDEMENT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 814751 | IMP,TSV,6.0,11.5,MTX,MG | DENTAL IMPLANT | DZE | ZIMMER DENTAL | TSVT6B10 | 1243759 | 00889024019881 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Required Intervention |