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

Model Number	626-00-46F
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding revision due to dislocation involving a mdm liner was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection, functional, dimensional and material analysis of device could not performed as no device is return for examination.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the event revision due to dislocation involving a mdm liner was reported.The event was not confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.Further information such as returned devices and more medical documentation are needed.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.Product surveillance will continue to monitor for trends.
Event or Problem Description
As reported: "pt.Presented after multiple dislocations of an mdm (right) total-hip, due to heterotopic-bone-growth/osteophyte-caused impingement around the acetabulum.Surgeon removed excess heterotopic-bony-structures, then changed the femoral head and mdm components as part of his protocol for this sort of revision.Surgeon opted to use a femoral head that mated with the stem's v40 taper instead of using another 'v40/ c-taper sleeve'".Spoke to rep.Due to heterotopic bone growth, impingement was being caused during certain points of movement, levering the adm/ mdm poly out of the mdm metal liner.After removing the impinging bone growth, the adm/ mdm poly insert, 28 +0 c-taper head, and adapter sleeve were revised to another adm/ mdm poly insert (same catalog number) and 28 +0 v40 ceramic head.Rep confirmed there are no allegations against the revised head and sleeve, provided the revision usage sheet, and confirmed that no further information will be released by the hospital or surgeon.

• 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: 11616216
• Report Number: 0002249697-2021-00607
• Device Sequence Number: 3099764
• Product Code: LZO
• UDI-Device Identifier: 04546540666024
• UDI-Public: 04546540666024
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2021

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: 11/20/2022
• Device Model Number: 626-00-46F
• Device Catalogue Number: 626-00-46F
• Device Lot Number: 61843201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 04/05/2021
• 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: 43 YR
• Patient Weight: 88