MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 32MM -3NK; HIP PROTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pneumonia (2011); Thrombosis/Thrombus (4440)
Date of Event	06/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial report: implant remains implanted.Associated products: medical product: g7 pps ltd acet shell 50d, catalog #: 010000662, lot #: 7001780.Medical product: g7 neutral arcomxl lnr 32mm d, catalog #: 010000731, lot #: 6628977.Medical product: tprlc xr fp type1 pps 7x134mm, catalog #: 51-102070, lot #: 6945473.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 the patient underwent initial right total hip arthroplasty performed (b)(6) 2021.One week postop, the patient developed pneumonia and was hospitalized for one week.Two weeks later, the patient developed a dvt and was treated in the hospital overnight.By the one month visit, the patient reported high satisfaction with only slight pain and problems.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: 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 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 no similar complaints reported with the item.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Capa: no corrective or preventive action required at this time.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 : device remains implanted.
Event or Problem Description
It was reported the patient underwent initial right total hip arthroplasty performed on (b)(6) 2021.One week postop, the patient developed pneumonia and was hospitalized for one week.Two weeks later, the patient developed a dvt and was treated in the hospital overnight.By the one month visit, the patient reported high satisfaction with only slight pain and problems.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay a correction.The correct lot number has been identified: lot #2983186.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 the patient underwent initial right total hip arthroplasty performed (b)(6) 2021.One week postop, the patient developed pneumonia and was hospitalized for one week.Two weeks later, the patient developed a dvt and was treated in the hospital overnight.By the one month visit, the patient reported high satisfaction with only slight pain and problems.

• Brand Name: CER BIOLOXD MOD HD 32MM -3NK
• Common Device Name: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 12406666
• Report Number: 3002806535-2021-00371
• Device Sequence Number: 14775333
• Product Code: LZO
• UDI-Device Identifier: 00887868248436
• UDI-Public: 00887868248436
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K042091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2021

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: 12-115114
• Device Lot Number: 2983186
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 09/08/2021; 10/13/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 09/10/2021; 10/13/2021
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 68