MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	542-11-50E
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Injury (2348); Inadequate Osseointegration (2646)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other 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
It was reported that patient's right hip was revised as the acetabular component was pulling out of the patient's acetabulum due to the cement mantle not interdigitating with the patient's native bone.Surgeon reported that there are no allegations against any stryker devices, but that patient factors (reported as "sick and unhealthy") were the cause.A trident all poly constrained acetabular insert (cemented) and a 32 +7.5 c-taper lfit head were revised to an ras cup with an adm/mdm liner construct (revision head not reported).Update 06 dec 2018: trident shell catalog # 542-11-50e lot # lynmee was implanted on (b)(6) 2008 and explanted on (b)(6) 2018.The trident shell has been added to the product grid.
Additional Manufacturer Narrative
Correction as per update received tuesday january 22nd 2019; the trident shell in situ from april 2008 was revised june 29, 2018 (altr), not on 21 november 2018.At that time, an all-poly constrained liner was cemented into the patient¿s native acetabulum.Emdr generated and submitted for shell under june revision mfr report #0002249697-2019-00408, therefore the emdr for the trident shell on this pi is being cancelled.
Event or Problem Description
It was reported that patient's right hip was revised as the acetabular component was pulling out of the patient's acetabulum due to the cement mantle not interdigitating with the patient's native bone.Surgeon reported that there are no allegations against any stryker devices, but that patient factors (reported as "sick and unhealthy") were the cause.A trident all poly constrained acetabular insert (cemented) and a 32 +7.5 c-taper lfit head were revised to an ras cup with an adm/mdm liner construct (revision head not reported).Update 06 dec 2018: trident shell catalog # 542-11-50e lot#lynmee was implanted on (b)(6) 2008 and explanted on (b)(6) 2018.The trident shell has been added to the product grid.Correction as per update received tuesday january 22nd 2019; the trident shell in situ from april 2008 was revised june 29, 2018 (altr), not on 21 november 2018.At that time, an all-poly constrained liner was cemented into the patient¿s native acetabulum.

• Brand Name: TRIDENT PSL HA CLUSTER 50MM
• 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: 8214674
• Report Number: 0002249697-2019-00018
• Device Sequence Number: 2745148
• Product Code: LPH
• UDI-Device Identifier: 07613327037265
• UDI-Public: 07613327037265
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• 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): 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 542-11-50E
• Device Lot Number: LYNMEE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 01/31/2019
• 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
• Patient Age: 82 YR
• Patient Weight: 87