MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIVERSAL IMPACTOR/POSTIONER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	2101-0200
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Surgeon was performing a direct anterior total hip.When he attempted to impact a size 52 trident ii shell after reaming to a 52, the cup would not stick in place, on fluoro it was showing that it bottomed to where he reamed however.He then decided to trial with a 54 window trial and it appeared to seat without further reaming but it didn't have "a great bite." he then decided to go with a 56 shell, but first put a 55 reamer in and he didn't even need to turn the reamer on as it appeared to sit in.He attempted to impact the 56 shell where it seemed to bottom out within a few mallet strikes of impaction, however with subsequent strikes with the mallet, the shell backed out a bit visualized on fluoro.We noticed after pulling the shell out and looking at fluro we noticed the cup inserter threads protruding significantly out the backside of the shell.Surgeon then decided to unthreaded the shell enough so the threads were no longer protruding and then proceeded to successfully impact the shell.The affected inserter was part number 2101-0200 lot 133114.It appeared to have 5 threads.We opened a second inserter (lot 133016) we had in house and that inserter had less threads (~3 lot 133114).Update 06/14/2018: spoke with rep.There are no complaints or allegations against the 52 mm shell.Hospital will not provide further information.
Additional Manufacturer Narrative
An event regarding assembly issue involving a cutting edge cup impactor was reported.The event was confirmed by product inspection.Conclusions: the dimensional inspection confirmed the reported event.A material analysis engineer examined the device and noted that the plug welds were fractured on both ends.An nc and capa were opened to further investigate the protrusion of the threaded stud.Material analysis confirmed no manufacturing non-conformance.Further, there have been no adverse trends associated with stud length.No further investigation is needed at this time.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Surgeon was performing a direct anterior total hip.When he attempted to impact a size 52 trident ii shell after reaming to a 52, the cup would not stick in place, on fluoro it was showing that it bottomed to where he reamed however.He then decided to trial with a 54 window trial and it appeared to seat without further reaming but it didn't have "a great bite." he then decided to go with a 56 shell, but first put a 55 reamer in and he didn't even need to turn the reamer on as it appeared to sit in.He attempted to impact the 56 shell where it seemed to bottom out within a few mallet strikes of impaction, however with subsequent strikes with the mallet, the shell backed out a bit visualized on fluoro.We noticed after pulling the shell out and looking at fluro we noticed the cup inserter threads protruding significantly out the backside of the shell.Surgeon then decided to unthread the shell enough so the threads were no longer protruding and then proceeded to successfully impact the shell.The affected inserter was part number 2101-0200 lot 133114.It appeared to have 5 threads.We opened a second inserter (lot 133016) we had in house and that inserter had less threads (~3 lot 133114).Update 14/jun/2018: spoke with rep.There are no complaints or allegations against the 52mm shell.Hospital will not provide further information.

• Brand Name: UNIVERSAL IMPACTOR/POSTIONER
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7674718
• Report Number: 0002249697-2018-02102
• Device Sequence Number: 1474788
• Product Code: LPH
• UDI-Device Identifier: 07613327211511
• UDI-Public: 07613327211511
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2018

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 Catalogue Number: 2101-0200
• Device Lot Number: 133114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 11/28/2018
• 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: 49 YR