MAUDE Adverse Event Report: BIOMET UK LTD. CER OPTION TYPE 1 TPR SLEVE +6; HIP PROTHESIS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation.Medical product: cer bioloxd option hd 28mm, catalog #: 650-1055, lot #: 3050674.Medical product: g7 osseoti 4 hole shell 64mm h, catalog #: 110010250, lot #: 6459948.Medical product: vivacit-e dm bearing 28x50mm, catalog #: 110031015, lot #: 64731446.Medical product: g7 dual mobility liner 50mm h catalog #: 110024466, lot #: 755990.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00414.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported, that the patient dislocated over the weekend and was revised for instability on (b)(6) 2021.
Event or Problem Description
It was reported, that the patient dislocated over the weekend and was revised for instability on (b)(6) 2021.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: product has not been returned for evaluation, therefore the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.Without the opportunity to examine the complaint item, a definitive root cause cannot be determined due to insufficient information.Review of complaint history identified 11 similar complaints for item 650-1055 including the initiating complaint in the last 3 years, and no additional complaints for the same item and lot combination.Review of complaint history identified no additional similar complaints for item 650-1068 in the last 3 years, and no additional complaints for the same item and lot combination.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.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.Device is used for treatment.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after 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.Multiple mdr reports were filed for this event, please see associated report: 3002806535-2021-00414-1.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text: product not returned.

• Brand Name: CER OPTION TYPE 1 TPR SLEVE +6
• Common Device Name: HIP PROTHESIS
• 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: 12539791
• Report Number: 3002806535-2021-00415
• Device Sequence Number: 11869159
• Product Code: LZO
• UDI-Device Identifier: 00887868271502
• UDI-Public: 00887868271502
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1068
• Device Lot Number: 2900905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 107 KG