MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM; IMPLANT

Catalog Number 502-03-54E

Device Problems Loose or Intermittent Connection (1371); Insufficient Information (3190)

Patient Problems Injury (2348); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 07/06/2015

Event Type  Injury  

Event Description

It was reported that the patient had a acetabular cup hip revision for a loosening cup.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

Additional devices added to this event: catalog: 6570-0-132, device description: delta v-40 ceramic head 32/0 lot:47517401.Catalog: 2030-6520-1, device description: 6.5 cancellous bone screw 20mm lot: mjah1t.Catalog: unk_shc, device description: unknown acolade stem lot:unknown.Catalog: 623-10-32e, device description: trident 10° x3 insert 32mm id lot:47617801.An event regarding cup loosening involving a tritanium shell was reported.Shell loosening and infection were confirmed.Method & results: -device evaluation and results: there was no evidence of bone ongrowth.The damage on the coating surface was likely explantation damage.A dimensional inspection was performed.There was no evidence of a dimensional issue.-medical records received and evaluation: a medical was performed and concluded that: "post revision surgery most likely a low-grade infection developed to contribute to tritanium cup loosening requiring second revision in 2015 but there is inadequate information to conclude this with any certainty." -device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.There was one other similar event for the reported sterile lot.Conclusions: a medical review was performed and concluded that the likely cause of the loosening was related to a low-grade infection and that there was no evidence of a device related issue.No further investigation is required at this time.If further relevant additional information becomes available, this investigation will be reopened.

Event Description

It was reported that the patient had an acetabular cup hip revision for a loosening cup.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4943948
• MDR Text Key: 6039818
• Report Number: 0002249697-2015-02484
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K143085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2015

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: 06/30/2018
• Device Catalogue Number: 502-03-54E
• Device Lot Number: 44168401
• Other Device ID Number: STER. LOT 1306GCM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/12/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 27 YR
• Patient Weight: 84