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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X35 SELF-TAP; PROSTHESIS, HIP

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ZIMMER MANUFACTURING B.V. BONE SCR 6.5X35 SELF-TAP; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/26/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).Concomitant medical products: catalog number: 00-8757-056-02, lot number: 62466930, brand name: continuum shell.Catalog number: 00-8751-012-36, lot number: 62874474, brand name: hxpe liner.Catalog number: 00-8777-036-02, lot number: 2826143, brand name: biolox head.Catalog number: 00-6250-065-40, lot number: 631718014, brand name: trilogy screw.Catalog number: 00-6250-065-25, lot number: 63176656, brand name: trilogy screw.Catalog number: 65-7711-009-20, lot number: 60707596, brand name: m/l taper stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device evaluated by mfr: device not returned for evaluation.
 
Event Description
It was reported that during a revision surgery , one of the fixation screws broke and was left implanted in the patients acetabulum.Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.  d4: (b)(4).Medical records were provided and reviewed by a health care professional.Review of the available records identified that 8 years post implantation patient experienced pain, elevated cobalt and chromium levels.Metallosis and pseudotumor were confirmed upon joint entry,corrosion was also noted on the stem¿s trunnion and femoral head.Patient underwent a revision surgery due to these complications.During the revision procedure, the locking ring was slightly bent and did not lock properly, so the acetabular cup was removed and during implantation of the new shell, the screw broke and was left inside the acetabulum.Reported event was confirmed by review of medical records provided.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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
No further event information available at the time of this report.
 
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Brand Name
BONE SCR 6.5X35 SELF-TAP
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
MDR Report Key8735765
MDR Text Key149230720
Report Number0002648920-2019-00463
Device Sequence Number1
Product Code MRA
Combination Product (y/n)N
PMA/PMN Number
K934765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 10/29/2019
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 Number00625006535
Device Lot Number62959152
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/02/2019
Initial Date FDA Received06/26/2019
Supplement Dates Manufacturer Received10/28/2019
Supplement Dates FDA Received10/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEE H10 NARRATIVE
Patient Outcome(s) Hospitalization; Other;
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