MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 28MM/+10; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number	06-2810
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
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.Product not available.
Event or Problem Description
The case was booked as a head and liner exchange.When the head was removed the surgeon decided the trunnion had damage and decided to remove the stem.
Additional Manufacturer Narrative
An event regarding incorrect selection involving a metal head was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -device evaluation and results: visual inspection: a review of the explanted device photograph by a clinician noted the following; {.} the explanted adm bearing and femoral head have no obvious pathology, at least no visible corrosion on the macroscopic explant view.{.} material analysis, functional and dimensional inspections could not be performed as the device was not returned.-medical records received and evaluation: a review of the provided x-rays by a clinical consultant indicated: {.} cup malposition has contributed to impingement between stem neck and cup rim causing stem neck damage with osteolysis around both stem and cup with periprosthetic fracture in the proximal femur requiring revision surgery with fracture stabilisation{.} and {.} use of skirted femoral head is probably a minor factor in this case.{.} -device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: the investigation concluded that cup malposition has contributed to impingement between stem neck and cup rim causing stem neck damage with osteolysis around both stem and cup with periprosthetic fracture in the proximal femur requiring revision surgery with fracture stabilization and use of skirted femoral head is probably a minor factor in this case.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The case was booked as a head and liner exchange.When the head was removed the surgeon decided the trunnion had damage and decided to remove the stem.Update:as per clinician review, cup malposition has contributed to impingement between stem neck and cup rim causing stem neck damage with osteolysis around both stem and cup with periprosthetic fracture in the proximal femur requiring revision surgery with fracture stabilization.

• Brand Name: C-TAPER COCR LFIT HEAD 28MM/+10
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8018560
• Report Number: 0002249697-2018-03545
• Device Sequence Number: 1382489
• Product Code: LWJ
• UDI-Device Identifier: 07613327016307
• UDI-Public: 07613327016307
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K993601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/11/2019

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 Catalogue Number: 06-2810
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 01/11/2019
• 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