MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	502-03-56E
Medical Device Problem Codes	Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	03/20/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.
Event or Problem Description
Per medical records in pi, revision of liner and femoral head for dislocation, shell and screws for revision for unspecified reason.Update: - (b)(6) 2014 head and acetabular revision due to chronic dislocation.
Additional Manufacturer Narrative
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.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.
Event or Problem Description
Per medical records in pi, revision of liner and femoral head for dislocation, shell and screws for revision for unspecified reason.Update: - (b)(6) 2014 head and acetabular revision due to chronic dislocation.
Event or Problem Description
Per medical records in pi, revision of liner and femoral head for dislocation, shell and screws for revision for unspecified reason.Update: - (b)(6) 2014 head and acetabular revision due to chronic dislocation.
Additional Manufacturer Narrative
Reported event: an event regarding dislocation involving malposition of the trident shell was reported.The event of dislocation was reported.The event of malposition was not reported.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: confirmation: a revision surgery of a rejuvenate stem (12/19/2013) can be confirmed but increased metal levels at that time cannot be confirmed.A subsequent revision can be confirmed for recurrent dislocation (03/20/2014, note: the stated existence of metallosis and poor tissues at the prior revision was not confirmed).A third revision (05/18/2021) can also be confirmed during which component to component impingement was noted with notching of the femoral neck and some metallosis in the tissues.Additional medical records would be required to define the event further.Root cause: the root cause of the first revision was pain and concern with the association of a recalled implant.Stated increased metal level could not be confirmed.The root cause of the second revision was instability.The root cause of the third revision cannot be ascertained without additional medical records.That said, impingement and notching of the femoral neck was noted at the time of the revision and this could certainly explain the concern and/or finding of increased metal levels (if confirmed) and metallosis.Product history review: review of the device history records indicate the 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.Conclusion: a review of the provided medical information by a clinical consultant indicated: confirmation: a revision surgery of a rejuvenate stem (12/19/2013) can be confirmed but increased metal levels at that time cannot be confirmed.A subsequent revision can be confirmed for recurrent dislocation (03/20/2014, note: the stated existence of metallosis and poor tissues at the prior revision was not confirmed).A third revision ((b)(6) 2021) can also be confirmed during which component to component impingement was noted with notching of the femoral neck and some metallosis in the tissues.Additional medical records would be required to define the event further.Root cause: the root cause of the first revision was pain and concern with the association of a recalled implant.Stated increased metal level could not be confirmed.The root cause of the second revision was instability.The root cause of the third revision cannot be ascertained without additional medical records.That said, impingement and notching of the femoral neck was noted at the time of the revision and this could certainly explain the concern and/or finding of increased metal levels (if confirmed) and metallosis.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 13168665
• Report Number: 0002249697-2022-00015
• Device Sequence Number: 5925671
• Product Code: LPH
• UDI-Device Identifier: 07613327040166
• UDI-Public: 07613327040166
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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: 08/31/2016
• Device Model Number: 502-03-56E
• Device Catalogue Number: 502-03-56E
• Device Lot Number: MKMY27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2011
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Unknown