MAUDE Adverse Event Report: . CER BIOLOXD OPTION HD 36MM; HIP PROTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted.Concomitant medical products: item name: g7 pps ltd acet shell 50d, item #: 010000662, lot # 6149828.Item name: g7 neutral e1 liner 36mm d, item #:010000856, lot # 6025178.Item name: echo b-mtrc mp fp ho 8, item #:193108, lot # 66931or.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product remains implanted.
Event or Problem Description
It was reported by clinical study(b)(6) that patient underwent left total hip arthroplasty.Subsequently, at the two year visit, the patient reported increased pain and a decrease in satisfaction.A bone scan was performed and mri planned.No further intervention has been reported at this time.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Hospital and surgeon information updated.D10: customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted.D11: item name : g7 pps ltd acet shell 50d, item #: 010000662, lot # 6149828.Item name : g7 neutral e1 liner 36mm d, item #:010000856, lot # 6025178.Item name : echo b-mtrc mp fp ho 8, item #:193108 lot # 66931or.The investigation is in process.Once the investigation has been completed, a follow-up/final mdr will be submitted.
Event or Problem Description
It was reported by clinical study echo_am166h that patient underwent left total hip arthroplasty.Subsequently, at the two year visit, the patient reported increased pain and a decrease in satisfaction.A bone scan was performed and mri planned.No further intervention has been reported at this time.
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 1 similar complaints reported with these item 650-1057.Trend identified as other complaint is from same hospital and same doctor.Root cause could not be identified in that case as product was not returned.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
Event or Problem Description
It was reported by clinical study (b)(4) that patient underwent left total hip arthroplasty.Subsequently, at the two year visit, the patient reported increased pain , stiffness and a decrease in satisfaction.A bone scan was performed and mri planned.Patient opted out of mri.

• Brand Name: CER BIOLOXD OPTION HD 36MM
• Common Device Name: HIP PROTHESIS
• Manufacturer (Section D): .; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9937646
• Report Number: 3002806535-2020-00229
• Device Sequence Number: 19008016
• Product Code: LPH
• UDI-Device Identifier: 00887868271397
• UDI-Public: 00887868271397
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K192683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1057
• Device Lot Number: 2904536
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: 05/19/2020; 08/14/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/01/2020; 08/19/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 56