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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Original total hip replacement (b)(6) 2010 patient had acetabular components and femoral head removed and replaced with tritanium shell and mdm liner surgeon recorded osteolysis as reason for revision on joint registry form.Left side.
Additional Manufacturer Narrative
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.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.Device not returned to the manufacturer.
Event or Problem Description
Original total hip replacement on (b)(6) 2010 patient had acetabular components and femoral head removed and replaced with tritanium shell and mdm liner surgeon recorded osteolysis as reason for revision on joint registry form.Left side.
Additional Manufacturer Narrative
Reported event: an event regarding osteolysis involving a trident shell was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the device indicated that the device had white residue on the outer surface of the shell consistent with implantation.The rim of the shell appears damaged from explanation.There is nothing observed on the device that would indicate a reason for revision.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this inquiry reports the revision of a total hip replacement about 12 years after implantation due to osteolysis.I cannot confirm with certainty that this event took place since i was not able to review post-operative xrays and operation report.I can confirm that there was damage to the acetabular liner as shown in the intra-operative photograph.No post revision photograph was submitted.No evidence of osteolysis was shown.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of liner damage and osteolysis are multifactorial including surgical factors, patient factors as well as possible impingement." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to osteolysis.Visual inspection of the device indicated that the device had white residue on the outer surface of the shell consistent with implantation.The rim of the shell appears damaged from explanation.There is nothing observed on the device that would indicate a reason for revision.A review of the provided medical records by a clinical consultant indicated the following: "i can confirm that there was damage to the acetabular liner as shown in the intra-operative photograph.No post revision photograph was submitted.No evidence of osteolysis was shown.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of liner damage and osteolysis are multifactorial including surgical factors, patient factors as well as possible impingement." further information such as pathology reports, additional pre- and post-operative x-rays and the primary/revision operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 13925265
• Report Number: 0002249697-2022-00438
• Device Sequence Number: 1790667
• Product Code: LPH
• UDI-Device Identifier: 07613327037319
• UDI-Public: 07613327037319
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2022

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: 03/31/2014
• Device Model Number: 542-11-58G
• Device Catalogue Number: 542-11-58G
• Device Lot Number: 29529501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 03/27/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male