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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK HEAD; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. UNK HEAD; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical devices: unknown stem, unknown cup, unknown liner.Foreign country: (b)(6).The reported event was identified during review of a journal article parker, m.J., & cawley, s.(2019).Treatment of the displaced intracapsular fracture for the ¿fitter¿ elderly patients: a randomised trial of total hip arthroplasty versus hemiarthroplasty for 105 patients.Injury, 50(11), 2009-2013.Doi:10.1016/j.Injury.2019.09.018 customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device 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: 0001822565 - 2020 - 02438, 0001822565 - 2020 - 02439, 0001822565 - 2020 - 02441.
 
Event Description
It was reported in a journal article that two patients in the thr group experienced superficial wound infection post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.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 ¿superficial wound infection" 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.Oral antibiotics and/or an i&d (incision & debridement) procedure can be used to promote the healing process, and this is a common procedure used to treat a non-healing incision site.
 
Event Description
Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.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 ¿superficial wound infection" 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.Oral antibiotics and/or an i&d (incision & debridement) procedure can be used to promote the healing process, and this is a common procedure used to treat a non-healing incision site.
 
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Brand Name
UNK HEAD
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key10243136
MDR Text Key198092814
Report Number0001822565-2020-02437
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Other;
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