MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT HEMISPHERICAL SOLID BACK SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	500-11-52E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.
Event or Problem Description
Problem occured when unable to seat acetabulum component.Surgery was a bilateral thr (problem occurred when replacing right hip).On (b)(6) 2016: the surgeon was unable to seat the cup due to the fact that he could not remove the impactor bolt from the cup "as stated by study coordinator, cup screwed too tightly onto the inserter.
Additional Manufacturer Narrative
An event regarding a disassembly issue between a trident shell and an unknown impactor bolt.The event was not confirmed.Method & results: device evaluation and results: a visual, dimensional and functional inspection was not performed as no devices were returned.Medical records received and evaluation: review of the provided medical records by a clinical consultant noted: "in summary, although the exact cause of the problem cannot be completely resolved due to lack of proper information, it is quite certain that the problem has been caused by an adverse mix of predominantly procedure-related factors with possibly a dense bone quality factor as a potential additional patient-related factor as discussed.This case is not device-related." device history review: all devices accepted into final stock conformed to specification.Complaint history review: there have been no similar previous reported events.Conclusions: review of the provided medical records by a clinical consultant concluded "in summary, although the exact cause of the problem cannot be completely resolved due to lack of proper information, it is quite certain that the problem has been caused by an adverse mix of predominantly procedure-related factors with possibly a dense bone quality factor as a potential additional patient-related factor as discussed.This pi case is not device-related." the event could not be confirmed nor the root cause determined due to the product being unavailable for evaluation.Further information such as return of the device is required to complete the investigation for determining root cause.If the devices and/or additional information become available, this investigation will be reopened.
Event or Problem Description
Problem occured when unable to seat acetabulum component.Surgery was a bilateral thr (problem occurred when replacing right hip).On (b)(6) 2016: the surgeon was unable to seat the cup due to the fact that he could not remove the impactor bolt from the cup "as stated by study coordinator, cup screwed too tightly onto the inserter.".

• Brand Name: TRIDENT HEMISPHERICAL SOLID BACK SHELL
• 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: 6225636
• Report Number: 0002249697-2017-00088
• Device Sequence Number: 709907
• Product Code: LPH
• UDI-Device Identifier: 04546540431868
• UDI-Public: (01)04546540431868(11)150921(17)200930(10)52903501
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2017

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: 09/30/2020
• Device Catalogue Number: 500-11-52E
• Device Lot Number: 52903501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2017
• Supplement Report FDA Received Date: 03/10/2017
• 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: 65 YR
• Patient Weight: 59