MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 32MM STD NK; HIP ARTHROPLASTY

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: medical product:echo por fem red lat nc 11x135, catalog #: 192511, lot #: 741870, medical product: g7 osseoti 3 hole shell 50mm d, catalog #: 110010243, lot #: 6214131, medical product: g7 neutral e1 liner 32mm d, catalog #: 010000848, lot #: 6148277.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It has been reported that the patient underwent right total hip arthroplasty.Subsequently the patient has received two revisions, both for unknown reasons.This complaint is reporting the second revision.
Additional Manufacturer Narrative
(b)(4).The following sections were updated: b4, d10, d11, g4, h2, h3, h6.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.H3 other text : product not returned.
Event or Problem Description
It has been reported that the patient underwent right total hip arthroplasty.Subsequently the patient has received two revisions, both for unknown reasons.This complaint is reporting the second revision.

• Brand Name: CER BIOLOXD MOD HD 32MM STD NK
• Common Device Name: HIP ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9614980
• Report Number: 3002806535-2020-00030
• Device Sequence Number: 524498
• Product Code: LZO
• UDI-Device Identifier: 00880304438804
• UDI-Public: 00880304438804
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K042091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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: 12-115115
• Device Lot Number: 117110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 02/06/2020
• 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: Hospitalization; Required Intervention