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

Model Number	626-00-38D
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.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.
Event or Problem Description
Mdm liner was impacted, later during the case was found to be dislodged.Surgeon wanted a new one.
Additional Manufacturer Narrative
An event regarding seating/locking issues involving an mdm liner was reported.The event was not confirmed.Device evaluation and results: visual inspection:the mdm liner was visually unremarkable.Dimensional inspection: the device was found to be dimensionally within specification as (b)(4).Medical records received and evaluation: no information was received for review with a clinical consultant.Device history review: all devices in the reported lot 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.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
Mdm liner was impacted, later during the case was found to be dislodged.Surgeon wanted a new one.

• Brand Name: MODULAR DUAL MOBILITY INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6591787
• Report Number: 0002249697-2017-01677
• Device Sequence Number: 11001431
• Product Code: LZO
• UDI-Device Identifier: 04546540666000
• UDI-Public: (01)04546540666000(11)161118(17)211130(10)57681804
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 626-00-38D
• Device Catalogue Number: 626-00-38D
• Device Lot Number: 57681804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Initial Date Received by Manufacturer: 04/27/2017
• Supplement Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 09/14/2017
• 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: Other