MAUDE Adverse Event Report: ZIMMER DENTAL ABUT FIX SPL 5.0 MM 6.5 F LARE 1 MM CUFF; DENTAL IMPLANT

Model Number	1519
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Osteolysis (2377)
Date of Event	12/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Device manufacturer date unknown / not provided.Peri-implantitis: a summary investigation has been completed for peri-implantitis events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for these events have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of a manufacturing or design defect that might lead to peri-implantitis occurring and escaping the available detections has been assessed and found remote and almost nonexistent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Event or Problem Description
It was reported that the implant was removed due to peri-implantitis.
Additional Manufacturer Narrative
The following sections have been updated:.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Peri-implantitis is an infectious disease that causes inflammation of the gum and the bone structure around a dental implant.Chronic inflammation causes bone loss, which can lead to implant failure thus its removal.Investigations performed for hundreds of events where either of these conditions, infection or bone loss, or both, have been reported, have concluded that the likely cause(s) for the implant failure in relation to these conditions are external factors.Those include, medical conditions (e.G., diabetes, bruxism, etc.), patient habits (e.G., smoking, bad oral hygiene routine) and user error (e.G., surgical technique).There has not been any instance where either infection and/or bone loss, and when right conditions prevail and led to peri-implantitis whether reported or not along with the other two, have resulted from a manufacturing or design defect.Furthermore, the probability of manufacturing or design defects that might lead to infection and result in bone loss occurring and escaping the available detections has been assessed and found remote and almost nonexistent.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.The analysis and result of investigations and the analysis of probability previously described are contained in the summary investigation reports performed for bone loss and infection, which are attached.Additionally, all device history record reviews verified that each implant was sterilized per procedure for every device.All complaint data used for the summary investigation was found to be conforming and did not meet capa/hhe/d/ie escalation.Therefore, there were no complaints which confirmed a manufacturing or design related issue that did or could cause or contribute to the reported event.The dhr was requested, however an electronic copy is not available for review.The investigation will be reopened and updated upon any new or additional information provided to this complaint.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product is within specifications.Complaint history review was performed for the reported lot number: 010089 for similar events and no other complaint was identified.Dec post market trending was reviewed and there were no actionable events or corrective actions for the reported event (peri-implantitis).As documented in the summary investigations, contributing factors for the reported event likely exist outside of zimmer biomet control, including those related to patient biological factors/condition and surgical technique.Based on the summary investigations, no malfunction occurred upon investigation.The reported events remain non-verifiable as they are a medical condition.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Peri-implantitis is an infectious disease that causes inflammation of the gum and the bone structure around a dental implant.Chronic inflammation causes bone loss, which can lead to implant failure thus its removal.Investigations performed for hundreds of events where either of these conditions, infection or bone loss, or both, have been reported, have concluded that the likely cause(s) for the implant failure in relation to these conditions are external factors.Those include medical conditions (e.G., diabetes, bruxism, etc.), patient habits (e.G., smoking, bad oral hygiene routine) and user error (e.G., surgical technique).There has not been any instance where either infection and/or bone loss, and when right conditions prevail and led to peri-implantitis whether reported or not along with the other two, have resulted from a manufacturing or design defect.Furthermore, the probability of manufacturing or design defects that might lead to infection and result in bone loss occurring and escaping the available detections has been assessed and found remote and almost nonexistent.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.The analysis and result of investigations and the analysis of probability previously described are contained in the summary investigation reports performed for bone loss and infection, which are attached.Additionally, all device history record reviews verified that each implant was sterilized per procedure for every device.All complaint data used for the summary investigation was found to be conforming and did not meet capa/hhe/d/ie escalation.Therefore, there were no complaints which confirmed a manufacturing or design related issue that did or could cause or contribute to the reported event.The dhr was requested, however an electronic copy is not available for review.The investigation will be reopened and updated upon any new or additional information provided to this complaint.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product is within specifications.Complaint history review was performed for the reported lot number 010009 for similar events and no other complaint was identified.Dec post market trending was reviewed and there were no actionable events or corrective actions for the reported event (peri-implantitis).As documented in the summary investigations, contributing factors for the reported event likely exist outside of zimmer biomet control, including those related to patient biological factors/condition and surgical technique.Based on the summary investigations, no malfunction occurred upon investigation.The reported events remain non-verifiable as they are a medical condition.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ABUT FIX SPL 5.0 MM 6.5 F LARE 1 MM CUFF
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15385431
• Report Number: 0002023141-2022-02352
• Device Sequence Number: 20286190
• Product Code: DZE
• UDI-Device Identifier: 00889024011717
• UDI-Public: (01)00889024011717(17)301231(10)010009
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K955619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2005
• Device Model Number: 1519
• Device Catalogue Number: 1881 SPLINE IMPLANT
• Device Lot Number: 010089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 02/06/2023; 02/08/2023; 02/16/2023; 02/19/2023
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 02/06/2023; 02/15/2023; 02/17/2023; 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female