MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CPS/OSS 5CM TPR ADAPT W/OSS SC 5CM; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Hematoma (1884); Impaired Healing (2378)

Event Date 05/19/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 36mm cocr mod hd +3mm, pn 11-363663, ln 058080, cps anchor plug 14mm, pn 178404, ln 794540, cps transverse pin 6pk 32mm m, pn 178527, ln 088220, cps transverse pin 6pk 36mm m, pn 178528, ln 156720, cps lg m-h f spindle 12mm pcha 600lb ass, pn 178496, ln 874940, cps centering sleeve 16mm ia16mm, pn 178538, ln 477400, cps nut co-cr-mo alloy, pn 178512, ln 814620, oss 9cm diaphyseal segment, pn 150467, ln 766360, oss finn mod prox fmrl lt 7cm, pn 150458 ln 848680, oss segmental stacking adapter, pn 150483, ln 868140.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00055, 0001825034-2020-00056, 0001825034-2020-00057, 0001825034-2020-00058, 0001825034-2020-00059, 0001825034-2020-00060, 0001825034-2020-00061, 0001825034-2020-00062, 0001825034-2020-00063, 0001825034-2020-00064.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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 has a long history of left hip complications and infection.The patient underwent a revision of a competitors fractured cable.During the revision, the patient was implanted with biomet components.Subsequently, the patient developed a hematoma at the surgical site requiring incision and drainage.No product was exchanged.Attempts were made to obtain additional information; however, none was available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure.The development of a postoperative hematoma after a procedure can be correlated with the surgical procedure and perioperative anticoagulation therapy to prevent dvt (prophylaxis).Patients may be at increased risk for developing hematomas if they have received fresh-frozen plasma, vitamin k, or hormonal therapy as well.Most hematomas resolve on their own, without surgical intervention, while some others do not.Larger hematomas may need to be surgically evacuated in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a review of the device history records will not be performed.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: CPS/OSS 5CM TPR ADAPT W/OSS SC 5CM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9549289
• MDR Text Key: 174369498
• Report Number: 0001825034-2020-00065
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K043547
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 178711
• Device Lot Number: 314840
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention