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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR HEAD 28MM/+10; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
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STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR HEAD 28MM/+10; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED Back to Search Results
Catalog Number 6001-2810
Device Problem Device Difficult to Setup or Prepare (1487)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2018
Event Type  malfunction  
Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.There have been no other events for the lot referenced.When completed, the evaluation summary will be submitted in a supplemental report.
 
Event Description
When the metal head 6001-2810 is pressed into dual mobile uh1-46-28 introperatively,head can't move freely without pushing with hand hard.Clunk occurs when moving.Maybe these two models can't be used and needed changing.Event update from (b)(6) 2018: surgical delay is nearly 1 hour.The surgeon spent nearly 20 minutes to find root cause.And then, the surgeon used nearly 40 minutes to confirm the final replacements size.
 
Manufacturer Narrative
An event regarding size/fit issue involving a metal head was reported.The event was not confirmed.Method & results: device evaluation and results: the reported metal head was returned assembled with the uh1 head.No scratches were observed on the part.Dimensional inspection was carried out on the returned device.The device is compliant with the drawing cd-6001-2610-ot rev w.Medical records received and evaluation: not performed as medical records were not received for review with a clinical consultant.Device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the reported event was not confirmed.The metal head was returned assembled with the uh1 head.A dimensional inspection was performed and found the device to be dimensionally acceptable.A functional test was not performed as it was not possible to replicate the failure mode after disassemby and cleaning/sterilization.If additional information becomes available, this investigation will be reopened.
 
Event Description
When the metal head 6001-2810 is pressed into dual mobile uh1-46-28 introperatively,head can't move freely without pushing with hand hard.Clunk occurs when moving.Maybe these two models can't be used and needed changing.Event update from (b)(6) 2018: surgical delay is nearly 1 hour.The surgeon spent nearly 20 minutes to find root cause.And then, the surgeon used nearly 40 minutes to confirm the final replacements size.
 
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Brand Name
C-TAPER COCR HEAD 28MM/+10
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8202353
MDR Text Key131714316
Report Number0002249697-2018-04145
Device Sequence Number1
Product Code LWJ
UDI-Device Identifier07613327016543
UDI-Public07613327016543
Combination Product (y/n)N
PMA/PMN Number
K993601
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 04/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2019
Device Catalogue Number6001-2810
Device Lot NumberMNM4WM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2018
Initial Date Manufacturer Received 11/30/2018
Initial Date FDA Received12/28/2018
Supplement Dates Manufacturer Received03/26/2019
Supplement Dates FDA Received04/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age77 YR
Patient Weight55
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