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

Catalog Number	1440-2011
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/13/2018
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 relevant reported discrepancies.There have been no other similar 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
A size 48mm cup was opened on the field by the nurse, st put the cup on the da curved impacted and physician inserted the cup.When the bolt was attempted to be removed, it would not go.The doctor removed the cup and replaced with a new cup.
Event or Problem Description
A size 48mm cup was opened on the field by the nurse, st put the cup on the da curved impacted and physician inserted the cup.When the bolt was attempted to be removed, it would not go.The doctor removed the cup and replaced with a new cup.
Additional Manufacturer Narrative
An event regarding a disassembly issue for a cup impactor bolt from an associated shell was reported.The event was confirmed.Dimensional inspection: not performed as dimensional aspects of the device are not in question.Functional inspection: not performed due to a material integrity issue as there is evidence from the visual inspection that the device is damaged.Material analysis: the material analysis report concluded the following: the material displacement observed on the cup impactor bolt and the acetabular cup was consistent with tightening with a force that was greater than hand-tight.Based on the given information, no identifiable material discrepancies were observed on the surfaces examined.Medical records received and evaluation: not performed as no medical records were provided.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot reported.Conclusions: the event was confirmed.It has been confirmed that this event is within the scope of capa opened for exceeded complaint rate for da impactor bolt disassembling from cup.It was determined that the root cause for this event was due to insufficient assembly instructions as this is a fairly new product and the user has not had previous practice on proper usage of the instrument.

• Brand Name: CUP IMPACTOR BOLT
• 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: 7404437
• Report Number: 0002249697-2018-01046
• Device Sequence Number: 19002811
• Product Code: LPH
• UDI-Device Identifier: 07613327196245
• UDI-Public: 07613327196245
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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 Expiration Date: 06/30/2022
• Device Catalogue Number: 1440-2011
• Device Lot Number: ERDHE1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 05/24/2018
• 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: 31 YR