MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-10-32E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: primary tritanium hemi cluster hole cup 54mm; cat#502-03-54e; lot#x552dr ,                                acetabular dome hole plug; cat#2060-0000-1; lot#rr4l47, 6.5 cancellous bone screw 30mm; cat#2030-6530-1; lot#p97wwl, 6.5 cancellous bone screw 20mm; cat#2030-6520-1; lot#t71x6t,   alumina v40-femoral head 32mm, +4mm nk; cat#6565-0-232; lot#61951201, size 4 accolade ii 127 deg; cat#6721-0435; lot#59940904.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
The customer reported that the patient who had been implanted with stryker devices developed an infection.

• Brand Name: TRIDENT 10° X3 INSERT 32MM 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: 7592358
• Report Number: 0002249697-2018-01785
• Device Sequence Number: 1698169
• Product Code: LPH
• UDI-Device Identifier: 07613327039856
• UDI-Public: 07613327039856
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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
• Report Date (Section B): 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 623-10-32E
• Device Lot Number: 55671901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/12/2018
• 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