MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH OMNIFIT HFX HIP STEM SIZE #07 132; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6070-0730A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
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 relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
As reported: "surgeon was performing a bipolar hip procedure¿.Stem was implanted¿ he attempted to put the head on the trunnion and it would not lock on¿.A second head was opened and it also would not lock¿.He removed the stem and implanted a second #7 hfx stem¿.He then put the head on to the trunnion, it locked without incident, he added the bipolar head, and reduced the hip".A surgical delay of 10 minutes was reported.Update 17/july/2019 (b)(6): spoke to rep.Right hip.The first attempted femoral head was ultimately implanted in the patient.The second head was wasted and will be returned.Rep was not present for the procedure.Usage sheet will be provided.
Event or Problem Description
As reported: "surgeon was performing a bipolar hip procedure¿.Stem was implanted¿he attempted to put the head on the trunnion and it would not lock on¿.A second head was opened and it also would not lock¿.He removed the stem and implanted a second #7 hfx stem¿.He then put the head on to the trunnion, it locked without incident, he added the bipolar head, and reduced the hip".A surgical delay of 10 minutes was reported.Update (b)(6) 2019 wg: spoke to rep.Right hip.The first attempted femoral head was ultimately implanted in the patient.The second head was wasted and will be returned.Rep was not present for the procedure.Rep will provide the usage sheet, but does not have access to any additional information.
Additional Manufacturer Narrative
An event regarding assembly issue involving an omnifit stem and a metal head was reported.The event was not confirmed.Method & results: -device evaluation and results: the stem was returned for evaluation.Damage was visible on the collar, neck and taper consistent with implantation and subsequent explantation damage.Dimensional inspection was performed in the cobalt chrome operations cell in mahwah.Only the taper dimensions were inspected as they related to the event.All dimensions for the taper were found to be in specification using igs 0002333 revision 6 and calibrated production gages.-medical records received and evaluation: not performed as no medical records were provided for review.-device history review: indicate all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: the stem was returned for evaluation.Damage was visible on the collar, neck and taper consistent with implantation and subsequent explantation damage.Dimensional inspection was performed in the cobalt chrome operations cell in mahwah.Only the taper dimensions were inspected as they related to the event.All dimensions for the taper were found to be in specification using igs 0002333 revision 6 and calibrated production gauges.Further information such as primary operative notes and photographs/video taken when the alleged event was identified is required to complete the investigation for confirming the event and determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: OMNIFIT HFX HIP STEM SIZE #07 132
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8869725
• Report Number: 0002249697-2019-02765
• Device Sequence Number: 16221216
• Product Code: JDI
• UDI-Device Identifier: 07613327023480
• UDI-Public: 07613327023480
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K031744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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: 11/30/2023
• Device Catalogue Number: 6070-0730A
• Device Lot Number: N789VV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 10/14/2019
• 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: 72 YR
• Patient Weight: 68