MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN CUP; UNK HIP IMPLANT

Catalog Number	623-00-28C
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Injury (2348); Joint Dislocation (2374)
Date of Event	12/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.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 3 dislocations.Then had surgery to replace device (b)(6) 2017.
Additional Manufacturer Narrative
D4 - device information was corrected.An event regarding dislocation was reported.The event was confirmed through medical review.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: provided medical records were provided to the clinician who indicated that: "no operative reports, no listing of the primary hip components, and no examination of explanted components are available.The first revision of the left total hip arthroplasty twenty years post-surgery for poly wear replaced the liner with a 28/0° insert, which subsequently proved to be unstable and dislocated three times anteriorly.Revision total hip arthroplasty is more prone to dislocation than primary procedures.Revision to an mdm bearing has since been stable and reduced.There is no evidence that this clinical situation was due to any factors of implant design, manufacturing or material of any stryker product." conclusion: it was reported that the patient was revised after reoccurring dislocations.The provided medical records were reviewed by clinician who concluded that no operative reports, no listing of the primary hip components, and no examination of explanted components are available.The first revision of the left total hip arthroplasty twenty years post-surgery for poly wear replaced the liner with a 28/0° insert, which subsequently proved to be unstable and dislocated three times anteriorly.Revision total hip arthroplasty is more prone to dislocation than primary procedures.Revision to an mdm bearing has since been stable and reduced.There is no evidence that this clinical situation was due to any factors of implant design, manufacturing or material of any stryker product.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, implant sheets and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
The patient had 3 dislocations.Then had surgery to replace device (b)(6) 2017.

• Brand Name: UNKNOWN CUP
• Common Device Name: UNK HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7946741
• Report Number: 0002249697-2018-03239
• Device Sequence Number: 19396953
• Product Code: LPH
• UDI-Device Identifier: 07613327039375
• UDI-Public: 07613327039375
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2018

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: 02/28/2021
• Device Catalogue Number: 623-00-28C
• Device Lot Number: RW04TT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 12/28/2018
• 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: 52 YR
• Patient Weight: 102