MAUDE Adverse Event Report: BIOMET UK LTD. 32MM MOD HEAD COCR -6MM NECK; ZIMMER BIOMET TYPE1 COCR HEADS

Model Number N/A

Device Problems Material Integrity Problem (2978); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 09/30/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Concomitant medical devices: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Associated products: medical product: taperloc bm/pc lat 10.0x140 t1, catalog no.: 11-103204bm, lot no.: 6423447.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 hi arthroplasty on (b)(6) 2019.Subsequently, a revision procedure due to metallosis was performed on (b)(6) 2021.Surgeon, mr (b)(6) was concerned about the severe amount of metallosis and thought it may be related wear of the femoral head and stem implants.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: no product was returned, and no pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records (dhr j6250944) have been checked and verify that the parts were manufactured and sterilised in accordance with the applicable specifications with no deviations or non-conformances found during manufacturing and inspection.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.It has been confirmed that the item is not within the scope or subject of any field actions or recalls which could be attributed to reported event.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 did not identify any issues.The root cause of the reported event cannot be determined with the information provided.No corrective or preventive 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.H3 other text: item not returned.

Event Description

It was reported that a patient underwent an initial hi arthroplasty on (b)(6) 2019.Subsequently, a revision procedure due to metallosis was performed on (b)(6) 2021.Surgeon, mr.(b)(6) was concerned about the severe amount of metallosis and thought it may be related wear of the femoral head and stem implants.

Manufacturer Narrative

(b)(4).This follow-up final report is being submitted to relay additional information as the product has been returned for evaluation.A dimensional inspection was conducted and the the 32mm modular head cocr -6mm neck item:163667 lot:j6250944 was found to be conforming to specification.The likely condition of the device when it left zimmer biomet is conforming to specification.The reported event has not been confirmed as the dimensional inspection shows the product is conforming to specification and the dhr review did not identify any issues.The root cause of the reported event cannot be determined with the information provided.

Event Description

It was reported that a patient underwent an initial hip arthroplasty.Subsequently, a revision procedure due to metallosis was performed approximately 2 years, 4 months later.Surgeon, mr (b)(6) was concerned about the severe amount of metallosis and thought it may be related wear of the femoral head and stem implants.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).This follow-up final report is being submitted to relay additional information.A ø32 mm cocrmo femoral head was received for analysis, due to revision after approximately 2 years and 4 months in service.Visual examination of the cocrmo head shows fine scratches on the bearing surface, which may have been caused by third body debris, however this cannot be confirmed without provision of radiographs and revision surgical notes.The taper surface of the cocrmo head shows some discolouration which may indicate some fretting has occurred.The root cause of the of the reported alval and metallosis could not be determined in this instance.Potential contributing factors such as the presence of third body debris within the joint space and/or component positioning cannot be discussed without provision of post-primary and pre-revision full pelvis radiographs, primary and revision surgery notes, and additional patient information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 32MM MOD HEAD COCR -6MM NECK
• Type of Device: ZIMMER BIOMET TYPE1 COCR HEADS
• 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: 12670885
• MDR Text Key: 277626325
• Report Number: 3002806535-2021-00452
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: 00887868308314
• UDI-Public: 00887868308314
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K042841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/16/2022

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: 163667
• Device Lot Number: J6250944
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 01/17/2022; 03/30/2022; 07/29/2022
• Supplement Dates FDA Received: 01/18/2022; 03/31/2022; 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention