MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD MOD HD 36MM -3 NK; HIP ARTHROPLASTY

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Erythema (1840); Swelling (2091); Impaired Healing (2378)

Event Date 03/15/2020

Event Type  Injury  

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 pps ltd acet shell 54f, catalog #: 010000664, lot #: 662979.Medical product: g7 neutral e1 liner 36mm f, catalog #: 010000858, lot #: 6623312.Medical product: echo por fmrl lat nc 9x125mm, catalog #: 192109, lot #: 925910.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent an initial right total hip arthroplasty performed (b)(6) 2020.Subsequently, the patient experienced delayed wound healing with drainage.Medical intervention was provided, and the outcome is pending.No further information has been provided at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h10.Additional information received: -on (b)(6) 2020, a superficial i&d was performed for wound dehiscence.-the outcome is pending.

Event Description

It was reported that the patient underwent an initial right total hip arthroplasty performed (b)(6) 2020.Subsequently, the patient experienced delayed wound healing with drainage.Medical intervention was provided, and the outcome is pending.Additional information received: on (b)(6) 2020, a superficial i&d was performed for wound dehiscence.The outcome is pending.

Event Description

It was reported that the patient underwent an initial right total hip arthroplasty performed (b)(6) 2020.Subsequently, the patient experienced delayed wound healing with drainage.Medical intervention was provided, and the outcome is pending.Additional information received: on (b)(6) 2020, a superficial i&d was performed for wound dehiscence.The outcome is pending.No additional information available.Final mdr report.

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.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 sterile certificate confirm product received adequate amount of radiation according to standard specification.Risk assessment: the root cause of the reported event of delayed wound healing could not be determined with the information related to the den provided to date.Therefore a specific line relating to a hazard could not be selected for assessment.There is no information that suggests this event is vice and so risk assessment cannot be conducted, if any further information is provided risk should be reassessed.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly h3 other text : product has not been returned.

• Brand Name: CER BIOLOXD MOD HD 36MM -3 NK
• Type of Device: HIP ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10003959
• MDR Text Key: 194334629
• Report Number: 3002806535-2020-00232
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: K061312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 12-115120
• Device Lot Number: 2986013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 143