MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 23MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-023; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6276-1-023
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
There was an order for restoration modular bha (including grip plate) from dealer on april 30.It was going to be used for subtrochanteric fracture on may 6.Sales rep couldn't have a meeting due to national holidays.Fracture was lateral, but surgeon decided to remove bone fragment containing the greater trochanter and use the stem.Sales rep told him that the proximal body of the stem was exposed and there was a risk of breakage.However, he insisted that fracture side is paralyzed, and carried out the operation.Since there was no greater trochanter, no calker, and no rotation index, version control did not work well.Although considerably back twisted, he thought it would not be dislocated.From assistant's view, it was already subluxed.

• Brand Name: 23MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-023
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11906905
• Report Number: 0002249697-2021-00948
• Device Sequence Number: 3589318
• Product Code: LPH
• UDI-Device Identifier: 04546540641083
• UDI-Public: 04546540641083
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2021

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 Model Number: 6276-1-023
• Device Catalogue Number: 6276-1-023
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 05/31/2021
• 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: 83