MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALL POLY CONSTRAINED INSERT 50MM; PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER

Catalog Number	69-2850
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	05/31/2018
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 reported discrepancies.There have been no other 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
The patient had surgery.The rep understands that the inner head and locking ring has dislocated from the cup body.The patient had a revision.
Event or Problem Description
The patient had surgery.The rep understands that the inner head and locking ring has dislocated from the cup body.The patient had a revision.Update: as per cup malposition contributing to impingement in combination with rupture/avulsion of the hip abductor sleeve from the greater trochanter due to surgical damage of the previous revision has caused in stability of the revision arthroplasty with an intraprosthetic dislocation of the constrained cup system as adverse outcome and requiring another revision.
Additional Manufacturer Narrative
Added update to executive summary.An event regarding disassociation and malposition involving a trident liner was reported.The event was confirmed.Method & results: product evaluation and results: not performed as product was not returned medical records received and evaluation: cup malposition contributing to impingement in combination with rupture/avulsion of the hip abductor sleeve from the greater trochanter due to surgical damage of the previous revision has caused in stability of the revision arthroplasty with an intraprosthetic.Dislocation of the constrained cup system as adverse outcome and requiring another revision.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the medical review indicated cup malposition contributing to impingement in combination with rupture/avulsion of the hip abductor sleeve from the greater trochanter due to surgical damage of the previous revision has caused in stability of the revision arthroplasty with an intraprosthetic dislocation of the constrained cup system as adverse outcome and requiring another revision.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ALL POLY CONSTRAINED INSERT 50MM
• Common Device Name: PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7659393
• Report Number: 0002249697-2018-02043
• Device Sequence Number: 13866162
• Product Code: KWZ
• UDI-Device Identifier: 07613327025477
• UDI-Public: 07613327025477
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K061654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 08/23/2018

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: 07/31/2018
• Device Catalogue Number: 69-2850
• Device Lot Number: MMKKDE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 08/23/2018
• 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: 80 YR
• Patient Weight: 67