MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +8 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-9-332
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event an event regarding disassociation involving a metal head was reported.The event was confirmed via clinician review.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "based upon the information supplied in this inquiry including the inquiry layout and x-rays supplied, i can confirm that the prosthetic femoral head did indeed displace due to either fracture or erosion/dissolution of the implant¿s femoral neck/trunnion." product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported the device was revised due to disassociation (head breaking off the trunnion).Clinician review of provided medical records indicated that the prosthetic femoral head did indeed displace due to either fracture or erosion/dissolution of the implant¿s femoral neck/trunnion.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that the patient's right hip was revised due to the head breaking off the trunnion.Patient is active and involved with manual labor.A femoral head and restoration modular proximal body were revised.Due to intra-operative damage to the stem/ neck junction, the restoration modular distal stem was also revised, adding 60 to 90 minutes to the procedure (intra-op event reported).Rep can provide additional pictures and otherwise confirmed that no further information will be released by the hospital or surgeon.Update 11/february/2021 wg: the rep is unaware if the shell or liner, which are competitor devices, were revised.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a metal head was reported.The event was confirmed via clinician review.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "based upon the information supplied in this inquiry including the inquiry layout and x-rays supplied, i can confirm that the prosthetic femoral head did indeed displace due to either fracture or erosion/dissolution of the implant¿s femoral neck/trunnion." product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on 05-mar-2014 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported the device was revised due to disassociation (head breaking off the trunnion).Clinician review of provided medical records indicated that the prosthetic femoral head did indeed displace due to either fracture or erosion/dissolution of the implant¿s femoral neck/trunnion.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not available.
Event or Problem Description
It was reported that the patient's right hip was revised due to the head breaking off the trunnion.Patient is active and involved with manual labor.A femoral head and restoration modular proximal body were revised.Due to intra-operative damage to the stem/ neck junction, the restoration modular distal stem was also revised, adding 60 to 90 minutes to the procedure (intra-op event reported).Rep can provide additional pictures and otherwise confirmed that no further information will be released by the hospital or surgeon.Update 11/february/2021 (b)(4): the rep is unaware if the shell or liner, which are competitor devices, were revised.

• Brand Name: 32MM +8 LFIT V40 HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11405372
• Report Number: 0002249697-2021-00368
• Device Sequence Number: 3381666
• Product Code: JDI
• UDI-Device Identifier: 07613327013122
• UDI-Public: 07613327013122
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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: 03/31/2019
• Device Model Number: 6260-9-332
• Device Catalogue Number: 6260-9-332
• Device Lot Number: 46721301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 03/10/2021
• 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: 62 YR