MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GAP PLATE SCREWS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	2080-0025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); Hip Fracture (2349); Osteolysis (2377)
Date of Event	08/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding osteolysis involving a restoration screw was reported.The event was confirmed through medical review.Device evaluation and results visual inspection was performed as part of the material evaluation and indicated nothing remarkable to report a material analysis has been performed.The report concluded: based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: indication for revision surgery was reported as pelvic discontinuity which is separation between superior and inferior segment of the acetabular bone.There are several patterns of separation but a central acetabular bone defect is usually the principle problem.The central acetabular bone area is already relatively thin under normal anatomic conditions but if acetabular bone loss problems emerge due to osteolysis, loosening, wear or other issues in or around the acetabular cup, the bone defect may become larger causing this bone area to become progressively weaker and thus susceptible to overload with a fatigue fracture as ultimate adverse outcome.No patient-related or device-related aspects are evident in this case, consistent with the type of problem and the known late sequels of previous causes of device failure.Does the review identify any procedural related factors that contributed to the event? retained ceramic wear debris in and around the hip joint space after a ceramic bearing fracture with revision in (b)(6) 2016 to contribute to persistent third-body wear in the joint bearing.Device history review: all 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 reported lot.Conclusion the investigation concluded that the event was caused by procedural factors.Retained ceramic wear debris in and around the hip joint space after a ceramic bearing fracture with revision in (b)(6) 2016 to contribute to persistent third-body wear in the joint bearing.The wear debris contributed to the patient¿s osteolysis which in turn instigated the bone defect to become larger, causing this bone area to become progressively weaker and thus susceptible to overload with a fatigue fracture as ultimate adverse outcome.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
It was reported that the patient's right hip was revised due to pelvic discontinuity.Intra-operatively, a small pocket of black tissue was found.The surgeon is unsure of where the black tissue came from as the patient did not have any cocr devices since a 2018 revision ((b)(4)).The 64 g trident hemispherical shell with 5 screws, 44g liner, and 44mm biolox head with +4 sleeve were revised (there are no allegations against the liner or head).Updated on 20-nov-2019 by sr based on medical review - osteolysis is evident around the trident shell - loose cup with pelvic separation is reported.
Additional Manufacturer Narrative
An event regarding osteolysis involving a restoration screw was reported.The event was confirmed through medical review.Device evaluation and results visual inspection was performed as part of the material evaluation and indicated nothing remarkable to report.A material analysis has been performed.The report concluded: based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: indication for revision surgery was reported as pelvic discontinuity which is separation between superior and inferior segment of the acetabular bone.There are several patterns of separation but a central acetabular bone defect is usually the principle problem.The central acetabular bone area is already relatively thin under normal anatomic conditions but if acetabular bone loss problems emerge due to osteolysis, loosening, wear or other issues in or around the acetabular cup, the bone defect may become larger causing this bone area to become progressively weaker and thus susceptible to overload with a fatigue fracture as ultimate adverse outcome.No patient-related or device-related aspects are evident in this case, consistent with the type of problem and the known late sequels of previous causes of device failure.Does the review identify any procedural related factors that contributed to the event? retained ceramic wear debris in and around the hip joint space after a ceramic bearing fracture with revision in (b)(6) 2016 to contribute to persistent third-body wear in the joint bearing.Device history review: all 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 reported lot.Conclusion: the investigation concluded that the event was caused by procedural factors as described in attached.Retained ceramic wear debris in and around the hip joint space after a ceramic bearing fracture with revision in (b)(6) 2016 to contribute to persistent third-body wear in the joint bearing.The wear debris contributed to the patient¿s osteolysis which in turn instigated the bone defect to become larger, causing this bone area to become progressively weaker and thus susceptible to overload with a fatigue fracture as ultimate adverse outcome.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
It was reported that the patient's right hip was revised due to pelvic discontinuity.Intra-operatively, a small pocket of black tissue was found.The surgeon is unsure of where the black tissue came from as the patient did not have any cocr devices since a 2018 revision (pi 2161928).The 64 g trident hemispherical shell with 5 screws, 44g liner, and 44mm biolox head with +4 sleeve were revised (there are no allegations against the liner or head).Updated on 20-nov-2019 by sr based on medical review: osteolysis is evident around the trident shell.Loose cup with pelvic separation is reported.

• Brand Name: GAP PLATE SCREWS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9513250
• Report Number: 0002249697-2019-04107
• Device Sequence Number: 19352714
• Product Code: JDI
• UDI-Device Identifier: 07613327037111
• UDI-Public: 07613327037111
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K943549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

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: 07/31/2020
• Device Catalogue Number: 2080-0025
• Device Lot Number: JV5NHL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 01/14/2020
• 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: 59 YR