MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 36MM/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	06-3600
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Joint Dislocation (2374)
Date of Event	07/01/2020
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.
Event or Problem Description
It was reported that the patient's right total hip was revised due to instability.
Additional Manufacturer Narrative
Reported event: an event regarding joint instability/ dislocation involving a metal head was reported.The event was confirmed by 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.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: instability of the hip was confirmed as was the revision surgery.The cause for the instability may be better assessed with review of sequential x-rays to evaluate the position of the acetabular component and changes thereof.Obtaining the implant may provide insight into the mechanism of failure of the polyethylene and failure of the cup to in-grow.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: clinician confirmed the reported hip instability.Clinician review revealed that the hip instability is possibly the result of acetabular loosening and liner fracture.The exact cause of the event could not be determined because insufficient information was provided.Further information such as sequential x-rays to evaluate the position of the acetabular component and changes and evaluation of the devices 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 total hip was revised due to instability.

• Brand Name: C-TAPER COCR LFIT HEAD 36MM/0
• 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: 10294566
• Report Number: 0002249697-2020-01484
• Device Sequence Number: 14416538
• Product Code: JDI
• UDI-Device Identifier: 07613327072365
• UDI-Public: 07613327072365
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K021310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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: 06-3600
• Device Catalogue Number: 06-3600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 10/06/2020
• 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: 80 YR