MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 58MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	542-11-58G
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.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.Should additional information become available it will be reported in a supplemental report.Device not available.
Event or Problem Description
The customer reported that : "the trident right hip prosthesis was placed the (b)(6) 2007 with the implants protheos.On (b)(6) 2020 we proceeded to change the head and the insert because it broke.".
Event or Problem Description
The customer reported that : "the trident right hip prosthesis was placed the (b)(6) 2007 with the implants protheos.On (b)(6) 2020 we proceeded to change the head and the insert because it broke.".
Additional Manufacturer Narrative
Corrected data: d4 - expiration date corrected to 30-sep-2012.H4 - manufacture date corrected to 24-sep-2007.Additional mfg narrative: reported event: an event regarding damage involving a trident shell was reported.The event was confirmed by inspection of the returned device.Method & results: -device evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2020 which indicated the device was returned fractured and examined with the aid of a stereo microscope at magnifications up to 50x.Damage was observed on the distal surface of the device consistent with impingement against a hip stem as well as articulation against a hard object.Energy dispersive spectroscopy analysis was performed on the device to confirm chemistry.A material analysis was conducted on the returned device which noted that damage on the distal surface of the trident psl ha cluster was consistent with impingement against a hip stem and articulation against a hard object.Eds showed that the cluster was consistent with astm f136, which is consistent with the drawing.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional and functional analysis were not performed as the device was returned in damaged condition.- clinician review: not performed as no medical records were made available.-device history review: review of the product history records indicate all devices were manufactured and accepted into final stock with no reported relevant discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: it was reported that the was revised to change the head and the insert because it broke.A material analysis was conducted on the returned device which noted that damage on the distal surface of the trident psl ha cluster was consistent with impingement against a hip stem and articulation against a hard object.Eds showed that the cluster was consistent with astm f136, which is consistent with the drawing.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.The root cause can not be determined as insufficient information was provided.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.

• Brand Name: TRIDENT PSL HA CLUSTER 58MM
• 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: 9763354
• Report Number: 0002249697-2020-00409
• Device Sequence Number: 688065
• Product Code: LPH
• UDI-Device Identifier: 07613327037319
• UDI-Public: 07613327037319
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 09/30/2012
• Device Model Number: 542-11-58G
• Device Catalogue Number: 542-11-58G
• Device Lot Number: 23763601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 06/03/2020
• 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: Hospitalization; Required Intervention