MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG INSERT 40MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-40E
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	10/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Thr revision.As you will see from the x-ray, the cup had spun but the surgeon was also concerned about potential of metalosis.Surgeon said main reason for revision was for metallosis.When asked if the surgeon would have performed a revision on said patient had the cup been fixed appropriately and in the right position, he said he thinks so.He said patient was experiencing a lot of pain and he puts this down to the metallosis between head and trunnion.Cup spinning was noticed via x-ray.Stem metallosis/trunionosis was noticed intra op as shown in pictures.The femoral head is one of the potentially affected heads as noted on this years lfit hazard.
Additional Manufacturer Narrative
An event regarding impingement involving a trident liner was reported.The reported event was confirmed based on review of medical records.Method & results: product evaluation and results: material analysis was performed and concluded that "[.]burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.Additionally, damage was observed on the distal rim of the insert consistent with impingement.[.] "based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." medical records received and evaluation: the provided medical records were reviewed by a consulting clinician who indicated a medical review could not be performed as additional records such as operative reports and serial x-rays are required.However, the provided x-ray confirms acetabular loosening.Product history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been no other event for this lot.Conclusions: the reported event was confirmed.A review of the provided x-ray by the consulting clinician confirms acetabular loosening which could have resulted in the impingement of the liner.Material analysis was performed and concluded that "[.]burnishing, scratching and third-body indentations were observed on the insert.These are common damage modes of uhmwpe.Additionally, damage was observed on the distal rim of the insert consistent with impingement.[.] "based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." further information such as serial x-rays and operative reports as well as patient history and follow up notes are needed to complete the investigation for determining root cause.If additional information is received, this investigation will be reopened and re-evaluated.
Event or Problem Description
Thr revision.As you will see from the x-ray, the cup had spun but the surgeon was also concerned about potential of metalosis.Surgeon said main reason for revision was for metalosis.When asked if the surgeon would have performed a revision on said patient had the cup been fixed appropriately and in the right position, he said he thinks so.He said patient was experiencing a lot of pain and he puts this down to the metalosis between head and trunion.Cup spinning was noticed via x-ray.Stem metalosis/trunionosis was noticed intra op as shown in pictures.The femoral head is one of the potentially affected heads as noted on this years lfit hazard.

• Brand Name: TRIDENT 0 DEG INSERT 40MM
• 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: 8285450
• Report Number: 0002249697-2019-00362
• Device Sequence Number: 141476
• Product Code: LPH
• UDI-Device Identifier: 07613327025323
• UDI-Public: 07613327025323
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K062419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 05/14/2019

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: 10/31/2017
• Device Catalogue Number: 623-00-40E
• Device Lot Number: MLPTJ1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 05/14/2019
• 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