MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 28MM -3 NK; HIP ARTHROPLASTY

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	12/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Concomitant medical products: medical product: g7 osseoti multihole 52mm e, catalog #: 110010264, lot #: 6506718, medical product: tprlc 133 t1 pps ho 17x154mm, catalog #: 51-104170, lot #: 6541698, medical product: unknown liner, catalog #: unknown , lot #: unknown.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 received a right hip arthroplasty and experienced stitch abscess in which, medical intervention was required.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.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.The sterilisation certificate was reviewed and confirmed that the product is sterilised within the specification range.A review of the complaint database over the last 3 years has found no similar complaints reported with the item 12-115109.Without the opportunity to examine the complaint product, the 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.Devices remain implanted.
Event or Problem Description
A clinical study reported the patient received a right hip arthroplasty, and experienced a stitch abscess shortly after the procedure.Medical intervention was required.

• Brand Name: CER BIOLOXD MOD HD 28MM -3 NK
• Common Device Name: HIP ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9786020
• Report Number: 3002806535-2020-00114
• Device Sequence Number: 2649771
• Product Code: LZO
• UDI-Device Identifier: 00887868248405
• UDI-Public: 0887868248405
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K042091
• 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): 03/19/2020

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: 12-115109
• Device Lot Number: 2983159
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/08/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 03/19/2020
• 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: 93