MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 28MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	623-10-28D
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The nurse reported to sales rep that an insert didn't match with trident cup.A backup insert was available and was used to complete the surgery.It was further reported that there was no adverse consequences.
Additional Manufacturer Narrative
Reported event: an event regarding alleged "size/fit issue" involving a trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: dimensional inspection of the returned device by the manufacturing engineer noted, "the returned device was re-inspected as per(b)(4) ver.2, and found to be failing for ¿c dimension, angle of taper, 0.079 dimension & q dimension¿ outside their respective tolerances.These features being out of specification are linked to the damaged observed on the part.A review of the original dhr confirmed that all parts inspected as part of this batch, were in specification at the time of manufacture.(the c dimension is aql2.5 in-process inspection).It is likely that the attempted implantation of the trident x3 liner resulted in the dimensions going out of specification.During the original in-process inspection, as per igs requirements, the ¿angle of taper, 0.079 dimension and q dimension¿ was checked on the first part of the original batch of 18 parts.All of the parts passed for these features at that stage.It follows that the ¿angle of taper, 0.079 dimension and q dimension diameter¿ feature went out of specification under the same attempted implantation of the trident x3 liner.All the features are linked to the outer sphere and locking detail of the part.The failure of these features and the damage observed on the front face, locking taper and outer sphere are deemed to be consistent with the attempted implantation of the trident x3 liner.Conclusion: the complaint is deemed not to be manufacturing related." -medical records received and evaluation: no medical records were received for review with a clinical consultant.-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 reported lot.Conclusions: the event was not confirmed and the root cause of the event could not be determined.Dimensional inspection of the returned device by the manufacturing engineer concluded." the complaint is deemed not to be manufacturing related." no further investigation is required.If additional relevant information becomes available this investigation will be reopened.
Event or Problem Description
The nurse reported to sales rep that an insert didn't match with trident cup.A backup insert was available and was used to complete the surgery.It was further reported that there was no adverse consequences.

• Brand Name: TRIDENT 10° X3 INSERT 28MM ID
• 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: 6547728
• Report Number: 0002249697-2017-01446
• Device Sequence Number: 627365
• Product Code: LPH
• UDI-Device Identifier: 07613327039764
• UDI-Public: (01)07613327039764(11)160421(17)210430(10)55501401
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2017

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: 04/30/2021
• Device Model Number: 623-10-28D
• Device Catalogue Number: 623-10-28D
• Device Lot Number: 55501401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 07/07/2017
• 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