MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SELF CENT HIP 42X28 RUST; HIP OTHER IMPLANT

Catalog Number 103542000

Device Problems Disassembly (1168); Fracture (1260)

Patient Problem Pain (1994)

Event Date 11/04/2014

Event Type  Injury  

Event Description

Patient was revised to address pain.It was also noted that the liner had fractured and disassociated from the shell of the bipolar construct.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Manufacturer Narrative

Depuy cpd examined the returned devices.The bipolar construct consists of three components: cup, liner, and locking ring.The locking ring is designed to hold the head within the cup.On the returned instrument the mating feature that locks the ring into the liner had been partially sheared off, while the mating feature on the liner was stretched and deformed.The shearing and deforming of these features would have allowed the femoral head to come free of the liner, where it would normally be retained by the locking ring.Significant forces would have been required to damage these mating features in this way.Additionally, the cup would have had to resist the force and remained stationary, where it is normally free to rotate within the acetabulum.If the cup had not been lodged in place, the forces would likely have resulted in normal rotational movement rather than failure of the construct.It is not clear what secured the head in place.There is minor marring to the rim of the cup, but nothing that would indicate that the cup was consistently impeded from free motion.Regardless, it is likely that something prevented the cup from rotating and the force was then transferred directly to the polymer locking ring.When the forces became sufficient, the head would have pushed through, leaving the damage seen in the returned implants.A search of the complaints databases finds no other reports against the product and lot code combinations since their release to distribution.Review of the 331218 device history records found no related manufacturing deviations or anomalies that would have contributed to the reported event.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.

Manufacturer Narrative

(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).

Manufacturer Narrative

Additional narrative: depuy cpd examined the returned devices.The bipolar construct consists of three components: cup, liner, and locking ring.The locking ring is designed to hold the head within the cup.On the returned instrument the mating feature that locks the ring into the liner had been partially sheared off, while the mating feature on the liner was stretched and deformed.The shearing and deforming of these features would have allowed the femoral head to come free of the liner, where it would normally be retained by the locking ring.Significant forces would have been required to damage these mating features in this way.Additionally, the cup would have had to resist the force and remained stationary, where it is normally free to rotate within the acetabulum.If the cup had not been lodged in place, the forces would likely have resulted in normal rotational movement rather than failure of the construct.It is not clear what secured the head in place.There is minor marring to the rim of the cup, but nothing that would indicate that the cup was consistently impeded from free motion.Regardless, it is likely that something prevented the cup from rotating and the force was then transferred directly to the polymer locking ring.When the forces became sufficient, the head would have pushed through, leaving the damage seen in the returned implants.A search of the complaints databases finds no other reports against the product and lot code combinations since their release to distribution.Review of the 331218 device history records found no related manufacturing deviations or anomalies that would have contributed to the reported event.The investigation can draw no conclusion with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be reopened as necessary.

• Brand Name: SELF CENT HIP 42X28 RUST
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4289301
• MDR Text Key: 5056994
• Report Number: 1818910-2014-32968
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK812672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/04/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 103542000
• Device Lot Number: 331218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 12/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/02/2014; 01/15/2015; 04/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2013
• 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): Required Intervention
• Patient Age: 63 YR