MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 032/0MM 12/14; CERAMIC FEMORAL HEAD PROSTHESIS

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Medical product: medacta not zimmer product, catalog #: unknown acetabulum cup, lot #: unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent an initial hip arthroplasty on an unknown date.Subsequently, a revision procedure was performed due to loose acetabulum implant from medacta (off label).Exchange of zimmer head only.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in australia.As the product has not been received, the investigation was limited to the information provided; a review of complaint history.Technical evaluation can not be completed from only photographs for a reported event of revision.One anteroposterior full-pelvis radiograph, taken on an unknown date, was provided for analysis with (b)(4).The patient has total hip replacements in both hips.Although the revised medacta acetabular shell appears to be the one on the left hip, the location of the revised components cannot be confirmed with the available information.Both femoral heads appear to be adequately sized and positioned.The patient, female, was 62 at the time of the reported event.The per states that the surgical technique for the product was utilised, and that it is unknown whether there were any contributing conditions related to the reported loosening.The manufacturing history records (mhr) for the biolox delta femoral head was not provided and therefore it could not be checked.Therefore, the version of the instructions for use (ifu) provided with the component cannot be determined with certainty.Two different ifus, one of which is likely to be the one provided with the femoral head, make the following recommendations: do not use biomet ttpa ceramic modular heads with femoral stems or acetabular components offered by non-biomet manufacturers.Mismatching of components or taper sizes can be expected to cause intraoperative or postoperative fracture of ceramic heads.Do not use prosthetic implants from other systems with biomet components due to the probability of incompatible sizing and bearing surfaces, which may lead to premature wear, malalignment and failure.The use of a zimmer biomet biolox delta femoral head with a biolox delta liner from other manufacturer goes against its recommended use and may have contributed to the reported loosening of the acetabular device.We have not been provided with any supporting documentation which could provide additional information.A review of the complaint database over the last 3 years has found no similar complaints reported with the item.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.The reported event states revision due to loosening of the acetabulum implant.The complaint is concerned with loss of fixation of the cup.As the complaint is related to the functionality of the femoral head, a risk line cannot be assigned in the i/o risk table for the ceramic head.Corrective action taken: no corrective action required at this time.Preventive action taken: no preventive action required at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : product has not been returned.

Event Description

It was reported that a patient underwent an initial hip arthroplasty on an unknown date.Subsequently, a revision procedure was performed due to loose acetabulum implant from medacta (off label).Exchange of zimmer head only.

• Brand Name: DELTA CER FEM HD 032/0MM 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: 10108628
• MDR Text Key: 195272349
• Report Number: 3002806535-2020-00273
• Device Sequence Number: 1
• Product Code: LZO
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

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: 650-0834
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEEH10
• Patient Outcome(s): Hospitalization; Required Intervention