MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 28MM, +0MM NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6565-0-128
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/15/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation catalog numbers and lot codes of other devices listed in this report: 4845-0203 abgii no3 cementless left v40 lot gy444105 unknown polyethylene insert lot unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
A 2012 operative report for the patient's left hip was provided.Noted in the report: "instability of the left hip joint secondary to cementless total hip replacement on the left.Femoral head exchange, revision to a metal head, diameter 28mm, length +12mm, taper v40.Joint is opened from the dorsal, revealing minor effusion.A smear is sent in for bacteriology.No longer possible to attach a ceramic head, because the prosthesis taper exhibited scratches and an extension by 12mm with ceramic head, diameter 28mm, is not possible." the report notes a 45 minute intra-operative delay to have the new femoral head delivered by taxi as one was not available in the o.R.An operative report for a revision on (b)(6) 2016 notes: "status secondary to revision of the modular head system performed on (b)(6) 2012 in the presence of recurrent dislocation." only the femoral head was revised in 2012.
Additional Manufacturer Narrative
Reported event an event regarding instability involving a ceramic head was reported.The event was not confirmed.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: cup liner and shell plus stem were retained although taper damage with scratches was documented in the 2012 revision report.No x-rays are available for review while no explants were returned for investigation.Some comments:- there is rather limited information while also no x-rays or explants are available for review and therefore, several important aspects may remain obscure.- given the absence of x-rays, component malposition cannot be excluded as relevant factor to contribute to failure, both with regard to the revision in 2012 for instability and the next revision surgery in 2016 for neck fracture.- cup malposition is a frequent source of trouble with hip instability including recurrent dislocation.There are some subtle signs for presence of impingement ¿between the lines¿ of the 2012 revision report although details were not provided and the problem quite likely was not recognized as relevant factor because the cup including liner were retained in this 2012 revision surgery.Impingement usually relates to malposition of one or more of the components, usually the cup.- cup malposition can be suspected but not proven.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: 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, 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.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
A 2012 operative report for the patient's left hip was provided.Noted in the report: "instability of the left hip joint secondary to cementless total hip replacement on the left.Femoral head exchange, revision to a metal head, diameter 28mm, length +12mm, taper v40.Joint is opened from the dorsal, revealing minor effusion.A smear is sent in for bacteriology.No longer possible to attach a ceramic head, because the prosthesis taper exhibited scratches and an extension by 12mm with ceramic head, diameter 28mm, is not possible." the report notes a 45 minute intra-operative delay to have the new femoral head delivered by taxi as one was not available in the o.R.An operative report for a revision on (b)(6) 2016 notes: "status secondary to revision of the modular head system performed on (b)(6) 2012 in the presence of recurrent dislocation." only the femoral head was revised in 2012.

• Brand Name: ALUMINA V40-FEMORAL HEAD 28MM, +0MM NK
• 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: 11972735
• Report Number: 0002249697-2021-00999
• Device Sequence Number: 3388339
• Product Code: JDI
• UDI-Device Identifier: 04546540390462
• UDI-Public: 04546540390462
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K023901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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: 6565-0-128
• Device Catalogue Number: 6565-0-128
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/23/2021
• 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: 49 YR