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

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Fever (1858); Pain (1994); Joint Dislocation (2374)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: cer bioloxd option hd 28mm catalog #: 650-1055 lot #: 179850, medical product: cer option type 1 tpr sleve -6 catalog #: 650-1064 lot #: 2887399, medical product: m2a-magnum pf cup 50odx44id catalog #: us157850 lot #: 296330, medical product: act artic e1 hip brg 28x44mm catalog #: ep-200150 lot #: 630420, medical product: taperloc por lat fmrl 9x137 catalog #: 11-103203 lot #: not reported.An additional mdr report was filed for this event, please see associated report: 3002806535-2019-00871.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 initial right total hip arthroplasty.Subsequently, the patient was revised due to metal on metal complications.Upon discharge from the hospital, the patient experienced recurrent dislocations, wound drainage with dehiscence, and fevers.The patient was again revised during which a blood loss, pseudotumor, hematoma, osteolysis, and tissue damage was noted with positive frozen sections, infection, wound complications, and pain.Implant wear was also noted due disassociation of the active articulation system.The acetabular shell, head, and liner were replaced, and the patient was placed on prolonged iv antibiotics.

• 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: 9321491
• Report Number: 3002806535-2019-00870
• Device Sequence Number: 2360949
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

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?: No
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention