MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Catalog Number	626-00-48G
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/21/2018
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.Investigation conclusion pending.
Event or Problem Description
Dislocation of femoral head from mdm liner insert.
Additional Manufacturer Narrative
An event regarding dislocation of a adm insert from a mdm liner was reported.The event was confirmed.Method & results: product evaluation and results: an inspection of the returned devices indicates that the head and adm insert dislocated from the mdm liner.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: on (b)(6) 2018 a revision of the left total hip arthroplasty was performed for a diagnosis of recurrent luxation prosthesis left hip.No patient demographics, no x-rays, no clinical or past medical history, and no operative report, date or description of the primary left total hip arthroplasty are available.There is no evidence that factors associated with implant manufacturing or materials are related to this clinical situation.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: a review of the provided medical records by a clinical consultant stated the following comment: on (b)(6) 2018 a revision of the left total hip arthroplasty was performed for a diagnosis of recurrent luxation prosthesis left hip.No patient demographics, no x-rays, no clinical or past medical history, and no operative report, date or description of the primary left total hip arthroplasty are available.There is no evidence that factors associated with implant manufacturing or materials are related to this clinical situation.An inspection of the returned devices indicates that the head and adm insert dislocated from the mdm liner.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Further information such as patient demographics, pre- and post-operative x-rays, clinical or past medical history, operative notes, date or description of the primary left total hip arthroplasty are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Dislocation of femoral head from mdm liner insert.

• Brand Name: MODULAR DUAL MOBILITY INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8175234
• Report Number: 0002249697-2018-04080
• Device Sequence Number: 2791930
• Product Code: LZO
• UDI-Device Identifier: 04546540666031
• UDI-Public: 04546540666031
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 03/22/2019

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 Expiration Date: 10/31/2022
• Device Catalogue Number: 626-00-48G
• Device Lot Number: 61100503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 03/22/2019
• 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
• Patient Age: 50 YR