MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 28MM; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Fever (1858); Pain (1994); Joint Dislocation (2374)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental mdr will be submitted.Concomitant medical products: medical product: cer option type 1 tpr sleve -6 catalog #: 650-1064 lot #: 2887399.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2019-00653.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent revision due to pain and metal on metal complications.During the revision, it was noted that the metal head would not disengage/release from the trunnion during explantation, extending the surgical time by an hour before the head and trunnion were separated.The patient was revised again.Intraoperatively it was identified the patient had a large pseudotumor, osteolysis around the acetabulum and femoral calcar region, bone and tissue damage.Corrosion was noted at the femoral head/adapter interface.The acetabular shell and femoral stem were retained and all other devices were revised.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.
Event or Problem Description
It was reported that a patient underwent revision due to pain and metal on metal complications.During the revision, it was noted that the metal head would not disengage/release from the trunnion during explantation, extending the surgical time by an hour before the head and trunnion were separated.The patient was revised again.Intraoperatively it was identified the patient had a large pseudotumor, osteolysis around the acetabulum and femoral calcar region, bone and tissue damage.Corrosion was noted at the femoral head/adapter interface.The acetabular shell and femoral stem were retained and all other devices were revised.

• Brand Name: CER BIOLOXD OPTION HD 28MM
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8854407
• Report Number: 3002806535-2019-00652
• Device Sequence Number: 2397103
• Product Code: LZO
• UDI-Device Identifier: 00880304521919
• UDI-Public: 00880304521919
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1055
• Device Lot Number: 179850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention