MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FM HD 036/+4MM 12/14; BIOLOX DELTA CER FEM HD LG

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Joint Dislocation (2374)

Event Date 12/02/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported, that: the patient underwent a hip procedure on (b)(6) 2015.Subsequently, the patient underwent a closed reduction under general anaesthesia due to pain and dislocation.Dislocation of hip prosthesis.Event took place 3 weeks after surgery.The patient reports that he was sitting on a bench, and when he stood up, he suddenly suffered great pain.The patient was treated the same day of the event: closed reduction under general anaesthesia.Orthosis was used for 3 weeks.Clinically asymptomatic after that.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records could not be conducted as dhr or lot number was provided.The device is used for treatment.The reported product was reviewed for compatibility with no issues noted.The product item no.650-0667 has not been involved in any previous field actions medical records/radiographs were not provided.A definitive root cause cannot be determined.The likely condition of the devices when they left zimmer biomet is conforming to specification.The reported event has not been confirmed as the products have not been returned for evaluation and the dhr review could not be conducted.The root cause of the reported event cannot be determined with the information provided.No corrective actions are required at this time.H3 other text : product not returned.

Event Description

It was reported, that the patient underwent a hip procedure on (b)(6) 2015.Subsequently, the patient underwent a closed reduction under general anaesthesia due to pain and dislocation.Dislocation of hip prosthesis.Event took place 3 weeks after surgery.The patient reports that he was sitting on a bench, and when he stood up, he suddenly suffered great pain.The patient was treated the same day of the event: closed reduction under general anaesthesia.Orthosis was used for 3 weeks.Clinically asymptomatic after that.

Event Description

It was reported, that the patient underwent a hip procedure on (b)(6) 2015.Subsequently, the patient underwent a closed reduction under general anaesthesia due to pain and dislocation.Dislocation of hip prosthesis.Event took place 3 weeks after surgery.The patient reports that he was sitting on a bench, and when he stood up, he suddenly suffered great pain.The patient was treated the same day of the event: closed reduction under general anaesthesia.Orthosis was used for 3 weeks.Clinically asymptomatic after that.

Manufacturer Narrative

(b)(4).This follow-up final report is being submitted due to amended complaint summary text.Complaint summary: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records could not be conducted as dhr or lot number was provided.The device is used for treatment.The reported product was reviewed for compatibility with no issues noted.A review of complaint history found no additional related issues for this item and the reported part and lot combination.The product item no.650-0667 has not been involved in any previous field actions medical records were not provided.A review of the radiographs on linked complaint (b)(4) conclude: superolateral dislocation of the right hip arthroplasty.There is no fracture.Overall implant fit is maintained.Regarding alignment, there is a superolateral dislocation.Bone quality appears osteopenic.A definitive root cause cannot be determined.The likely condition of the devices when they left zimmer biomet is conforming to specification.The reported event has not been confirmed as the products have not been returned for evaluation and the dhr review could not be conducted.The root cause of the reported event cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.The investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and further investigated.

Event Description

It was reported, that the patient underwent a hip procedure on (b)(6), 2015.Subsequently, the patient underwent a closed reduction under general anaesthesia due to pain and dislocation.Dislocation of hip prosthesis.Event took place 3 weeks after surgery.The patient reports that he was sitting on a bench, and when he stood up, he suddenly suffered great pain.The patient was treated the same day of the event: closed reduction under general anaesthesia.Orthosis was used for 3 weeks.Clinically asymptomatic after that.

Manufacturer Narrative

(b)(4).This follow-up final report is being submitted due to amended complaint summary text.Complaint summary: no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records could not be conducted as dhr or lot number was provided.The device is used for treatment.The reported product was reviewed for compatibility with no issues noted.A review of complaint history found no additional related issues for this item and the reported part and lot combination.The product item no.650-0667 has not been involved in any previous field actions medical records were not provided.A review of the radiographs on linked complaint (b)(4) conclude: superolateral dislocation of the right hip arthroplasty.There is no fracture.Overall implant fit is maintained.Regarding alignment, there is a superolateral dislocation.Bone quality appears osteopenic.A definitive root cause cannot be determined.The likely condition of the devices when they left zimmer biomet is conforming to specification.The reported event has not been confirmed as the products have not been returned for evaluation and the dhr review could not be conducted.The root cause of the reported event cannot be determined with the information provided.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.The investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and further investigated.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Additional product information received: item: 650-0838 (instead of 650-0667).Lot: 2015050622.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported, that the patient underwent a hip procedure on (b)(6) 2015.Subsequently, the patient underwent a closed reduction under general anaesthesia due to pain and dislocation.Dislocation of hip prosthesis.Event took place 3 weeks after surgery.The patient reports that he was sitting on a bench, and when he stoodup, he suddenly suffered great pain.The patient was treated the same day of the event: closed reduction under general anaesthesia.Orthosis was used for 3 weeks.Clinically asymptomatic after that.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: the complaint states: it was reported the patient underwent a hip procedure on (b)(6)2015.Subsequently, the patient underwent a closed reduction under general anesthesia due to pain and dislocation.Dislocation of hip prosthesis.Event took place 3 weeks after surgery.The patient reports that he was sitting on a bench, and when he stood up, he suddenly suffered great pain.The patient was treated the same day of the event: closed reduction under general anesthesia.Orthosis was used for 3 weeks.Clinically asymptomatic after that.Event did not occur during surgery.The device is used for treatment.Complaint could not be confirmed with the available information and as the product was not returned for review.Visual inspection could not be conducted as product was not returned for review.Dimensional check was not carried out as product was not returned for review.Material review of inspection certificate and certificate of conformance confirms material compliance to specification.A review of the manufacturing history record confirms that the device and packaging was processed and verified in line with the specification and quality characteristics and was completed as defined by zimmer biomet.The product item no.650-0838, lot: 2015050622, has not been involved in any previous capas or field actions.No corrective actions are required at this time.The product has been in the field for approximately 7 years, however the dislocation was reported 3 weeks after the initial implant in (b)(6) 2015.The definitive root cause could not be defined with the available information.On review of the provided x-rays, the assistant research manager stated that she was not able to measure the inclination angle of the acetabular shell as the images did not allow her to view the full pelvis.Post-primary and pre-revision radiographs prior to the dislocation could not be provided to support the investigation.It was confirmed that the reported harm/hazardous situation, dislocation, is addressed in the associated risk management file for the reported product.However, as the failure mode associated with the reported event is unknown, a specific risk line item cannot be identified.The overall risk is considered to be low.Investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and investigated further.

Event Description

It was reported, that the patient underwent a hip procedure on (b)(6) 2015.Subsequently, the patient underwent a closed reduction under general anaesthesia due to pain and dislocation.Dislocation of hip prosthesis.Event took place 3 weeks after surgery.The patient reports that he was sitting on a bench, and when he stood up, he suddenly suffered great pain.The patient was treated the same day of the event: closed reduction under general anaesthesia.Orthosis was used for 3 weeks.Clinically asymptomatic after that.

• Brand Name: DELTA CER FM HD 036/+4MM 12/14
• Type of Device: BIOLOX DELTA CER FEM HD LG
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13083626
• MDR Text Key: 282772654
• Report Number: 3002806535-2021-00539
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/17/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-0838
• Device Lot Number: 2015050622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/24/2021
• Supplement Dates Manufacturer Received: 01/18/2022; 01/17/2022; 01/17/2022; 01/24/2022; 03/16/2022
• Supplement Dates FDA Received: 01/21/2022; 02/02/2022; 02/02/2022; 02/08/2022; 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization