MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 9X125MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378); Patient Problem/Medical Problem (2688)

Event Date 03/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 010000664 ¿ g7 shell ¿ 662979, 010000858 ¿ g7 neutral liner ¿ 6623312, 12-115120 ¿ ceramic head ¿ 2986013.Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 01627.0001825034 - 2020 - 01628.

Event Description

It was reported that patient experienced delayed would healing and draining approximately 1 month post initial right total hip arthroplasty.Approximately 3 weeks later, a superficial irrigation and debridement was performed for would dehiscence.The outcome is pending.No revision of devices has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

Medical review of the reported event concluded that it is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.A surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.The expression 'wound concerns' or 'non-healing wound' would imply that the appearance of the wound deviates from what a surgical wound should appear as.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.It is noted an i&d (incision & debridement) was performed on the superficial non-healing wound.An i&d procedure can be used to promote the healing process, and this is a common procedure used to treat a non-healing incision site.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.

• Brand Name: ECHO POR FMRL LAT NC 9X125MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9952960
• MDR Text Key: 187399503
• Report Number: 0001825034-2020-01629
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 00880304463325
• UDI-Public: (01)00880304463325
• Combination Product (y/n): N
• PMA/PMN Number: K070274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• 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: 192109
• Device Lot Number: 925910
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 143