MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR HEAD 28MM/+10; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number	6001-2810
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.

• Brand Name: C-TAPER COCR HEAD 28MM/+10
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8202353
• Report Number: 0002249697-2018-04145
• Device Sequence Number: 1656795
• Product Code: LWJ
• UDI-Device Identifier: 07613327016543
• UDI-Public: 07613327016543
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K993601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 6001-2810
• Device Lot Number: MNM4WM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Weight: 55