MAUDE Adverse Event Report: BIOMET UK LTD. FORTE CER FEM HD D28/0MM 12/14; CERAMIC FEMORAL HEAD PROSTHESIS

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 11/03/2008

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Concomitant medical products: medical product: aura ii hip ha coated rt sz 6, catalog #: p0126h06, lot #: 0000121476.Medical product: plasmacup sc size 52mm, catalog #: nh052t, lot #: 51243944.Medical product: sc/msc pe-insert 28mm 52/54 asym, catalog #: nh473, lot #: 51245306.Postal code: (b)(6).Occupation: chairman.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Data from (b)(6) : review the performance of implants following a review of the data conducted in march 2019 on aura ii, on 304 primaries surgeries, 33 have been revised during the first year postoperative.This complaint is related to revision due to unspecified reason: it was reported that a patient underwent revision (hip, right) due to unspecified reason, 3 years after implantation.The cup, the head and the stem were removed.

Event Description

Data from njr (national joint registry - uk) : review the performance of implants following a review of the data conducted in (b)(6) 2019 on aura ii, on 304 primaries surgeries, 33 have been revised during the first year postoperative.This complaint is related to revision due to unspecified reason: it was reported that a patient underwent revision (hip, right) due to unspecified reason, 3 years after implantation.The cup, the head and the stem were removed.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Report source, foreign - event occurred in united kingdom.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with x-rays or any supporting documentation which could provide additional information.Response received from njr: no information available.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaints database over the last 3 years has found no similar complaints for this item code 164191 for unknown reason.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: risk management report documents the estimated residual risk associated with the reported event.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk table could not be selected for comparison.At this time, no risk assessment can be conducted since the harm or reason for revision has not been be reported.If further information regarding the root cause of the reported event or reason for revision are provided, the risk will be re-assessed.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Product has not been returned.

Manufacturer Narrative

(b)(4).This final / follow-up report is being submitted to make a correction.Correction of d4: udi: (b)(4).

Event Description

Data from njr (national joint registry - uk) : review the performance of implants following a review of the data conducted in march 2019 on aura ii, on 304 primaries surgeries, 33 have been revised during the first year postoperative.This complaint is related to revision due to unspecified reason: it was reported that a patient underwent revision (hip, right) due to unspecified reason, 3 years after implantation.The cup, the head and the stem were removed.

• Brand Name: FORTE CER FEM HD D28/0MM 12/14
• Type of Device: CERAMIC FEMORAL HEAD PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10108478
• MDR Text Key: 195269753
• Report Number: 3002806535-2020-00270
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00501927935036
• UDI-Public: 0501927935036
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: N/A
• Device Catalogue Number: 164191
• Device Lot Number: 804227
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR