MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA CLUSTER 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	542-11-56F
Medical Device Problem Codes	Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	06/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.
Event or Problem Description
Anterior dislocation of right hip on (b)(6) following right tha (b)(6) 2017.Patient presentation to ed.Patient sat down from standing and experienced a sudden pop sensation in anterior groin.Presented to ed.Physician(s) performed a closed reduction of dislocated right hip and hip x-ray.Based on the investigation results, shell malposition was confirmed.
Additional Manufacturer Narrative
An event regarding dislocation involving a trident shell was reported.Clinical review confirmed shell malposition.Device evaluation and results: not performed as the reported device was not returned for evaluation.Medical records received and evaluation: a clinical review concluded: "procedure-related factors: cup position regarding anteversion and elevated position.Femoral component position issues may be suspected but remain unproven.The inappropriate use of the lipped liner.The use of a skirted femoral head.Osteophytes remaining around the hip.Patient-related factors.The implications of a somewhat abnormal anatomy of the patient.Device-related factors: none.Diagnosis: retained osteophytes along the hip joint margin in concert with the presence of multiple dislocation promoting factors related to cup (and/or possibly stem) position in further combination with inappropriate selection of components plus presence of a somewhat abnormal patient anatomy around the hip have contributed to significant dislocation risk of the arthroplasty with dislocation requiring a closed reduction without revision surgery at this time." device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the medical review concluded: "retained osteophytes along the hip joint margin in concert with the presence of multiple dislocation promoting factors related to cup (and/or possibly stem) position in further combination with inappropriate selection of components plus presence of a somewhat abnormal patient anatomy around the hip have contributed to significant dislocation risk of the arthroplasty with dislocation requiring a closed reduction without revision surgery at this time" if further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Anterior dislocation of right hip on (b)(6) following right tha (b)(6) 2017.Patient presentation to ed.Patient sat down from standing and experienced a sudden pop sensation in anterior groin.Presented to ed.Physician(s) performed a closed reduction of dislocated right hip and hip x-ray.Based on the investigation results, shell malposition was confirmed.

• Brand Name: TRIDENT PSL HA CLUSTER 56MM
• 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: 7032490
• Report Number: 0002249697-2017-03329
• Device Sequence Number: 156422
• Product Code: LPH
• UDI-Device Identifier: 07613327037227
• UDI-Public: 07613327037227
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2017

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: 09/20/2021
• Device Catalogue Number: 542-11-56F
• Device Lot Number: 56281804
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/12/2017
• 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: 69 YR
• Patient Weight: 121