MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 40MM; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Remains implanted.Concomitant medical products: medical product: g7 hi-wall e1 liner 40mm i catalog #: 010000945 lot #: 6046200, medical product: g7 pps ltd acet shell 66i catalog #: 010000670 lot #: 6275966, medical product: tprlc 133 t1 pps so 22x164mm catalog #: 51-103220 lot #: 6143346, medical product: cer opt type 1 tpr sleve 0mm catalog #: 650-1066 lot #: 2959127.The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
Event or Problem Description
Patient underwent primary left tha.Subsequently, the patient experienced left tha dislocation and closed reduction was performed.
Additional Manufacturer Narrative
(b)(4).As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found 2 similar complaints reported with the item.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient 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.
Event or Problem Description
Patient underwent primary left tha.Subsequently, the patient experienced a dislocation and closed reduction was performed.

• Brand Name: CER BIOLOXD OPTION HD 40MM
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9184257
• Report Number: 3002806535-2019-00815
• Device Sequence Number: 2413814
• Product Code: LZO
• UDI-Device Identifier: 00887868248597
• UDI-Public: 00887868248597
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1058
• Device Lot Number: 2982812
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 03/18/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 98