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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X20 SELF-TAP; PROSTHESIS, HIP

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ZIMMER BIOMET, INC. BONE SCR 6.5X20 SELF-TAP; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Device Slipped (1584); Failure to Osseointegrate (1863)
Patient Problems Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Event Date 06/12/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: part: 00801803202, lot: unk; part: unk stem, lot: unk; part: unk cup, lot: unk; part: unk liner, lot: unk.Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a left total hip arthroplasty on (b)(6) 2010 due to osteoarthritis.Zimmer biomet products were implanted without complications.The patient was revised on (b)(6) 2017 due to failed hip arthroplasty.Per office notes dated (b)(6) 2017, the patient presented with pain and was limping with pain.Lab reports dated (b)(6) 2017 showed the patient had elevated metal ions in blood - cobalt 10.6 (normal <1.9), chromium 4.0 (normal <3.6), and an x-ray review revealed radiolucency around the acetabular cup and screw.During the revision procedure on (b)(6) 2017, the cup was found to be loose.There was black metallosis around the head and neck.Scar tissue was excised, and the trunnion exhibited trunnionosis.Gluteus medius and minimus were found to be partially torn.Tendons were repaired and the femoral stem was left intact.The femoral head was replaced with a new zimmer biomet product.The cup and liner were replaced with competitor's products.No other findings/complications were noted.Part and lot identification are necessary for review of device history records, neither were provided for the stem, shell and screw.A definitive root cause cannot be determined.A summary of the investigation has been sent to the complainant.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.
 
Event Description
It was reported that patient underwent a revision procedure 17 years post-implantation due to pain and elevated metal ions.During the revision, significant trunnionosis was noted with tears in the gluteus medius and minimus.The acetabular cup was aseptically loose with only fibrous but no bony ingrowth.Black metallosis noted around the head and neck.Gluteus medius and minimus were found to be partially torn.The femoral stem was left intact, all other components were replaced without complication.No further event information available at the time of this report.
 
Manufacturer Narrative
The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b5; g3; h2; upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
 
Event Description
Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number (b)(4).
 
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Brand Name
BONE SCR 6.5X20 SELF-TAP
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12084641
MDR Text Key258946957
Report Number0001822565-2021-01778
Device Sequence Number1
Product Code MRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K934765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 04/05/2022
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? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number00625006520
Device Lot Number61336952
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/26/2021
Initial Date FDA Received06/29/2021
Supplement Dates Manufacturer Received10/20/2021
03/21/2022
Supplement Dates FDA Received11/17/2021
04/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexFemale
Patient Weight72 KG
Patient RaceWhite
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