MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 36MM/+10; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6260-9-336

Device Problems Degraded (1153); Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 04/19/2023

Event Type  Injury  

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.H3 other text: device not returned to the manufacturer.

Event Description

It was reported that the patient's left hip was revised after patient complaint of pain.Pre- and intra-operatively, the following were noted: head dissociation, trunnion wear, liner wear.Patient was revised to a restoration modular stem construct with ceramic head and x-3 liner.

Manufacturer Narrative

Reported event: an event regarding disassociation involving a metal head was reported.The event was confirmed via evaluation of the returned devices.Method & results: -product evaluation and results: visual inspection: the device was returned for evaluation.Scratches are visible on the rim of the head.Explantation damage was observed.Damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.No further material analyses were performed.Material analysis: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.No further material analyses were performed.-clinician review: no medical records were received for review with a clinical consultant.-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 that the patient was revised due to disassociation of the head from the stem.The device was returned for evaluation.Scratches are visible on the rim of the head.Explantation damage was observed.Damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.No further material analyses were performed.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that the patient's left hip was revised after patient complaint of pain.Pre- and intra-operatively, the following were noted: head dissociation, trunnion wear, liner wear.Patient was revised to a restoration modular stem construct with ceramic head and x-3 liner.

• Brand Name: V40 COCR LFIT HEAD 36MM/+10
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16910692
• MDR Text Key: 314988894
• Report Number: 0002249697-2023-00504
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327032321
• UDI-Public: 07613327032321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 6260-9-336
• Device Catalogue Number: 6260-9-336
• Device Lot Number: MLDH6A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male