MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN 32MM HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problems Corroded (1131); Device Dislodged or Dislocated (2923)

Patient Problems Host-Tissue Reaction (1297); Joint Dislocation (2374)

Event Date 10/09/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.The product identification necessary to review manufacturing history was not provided.Initial reporter: this article was written by: nn.J.Lash,m.R.Whitehouse, n.V.Greidanus, d.S.Garbuz, b.A.Masri, c.P.Duncan.

Event Description

Information was received based on the journal article entitled, delayed dislocation following metal-on-polyethylene arthroplasty of the hip due to ¿silent¿ trunnion corrosion.The aim of the article was to present a case series of ten metal-on-polyethylene total hip arthroplasties (mop thas) with delayed dislocation associated with unrecognized adverse local tissue reaction due to corrosion at the trunnion and pseudotumour formation.It was reported that a patient was revised 62 months post-implantation due to dislocation, pseudotumour, and taper corrosion.No further information has been provided and patient outcome is unknown.

Manufacturer Narrative

(b)(6).This follow-up report is being submitted to relay additional information.Concomitant medical products - unknown m/l taper femoral stem, unknown trilogy acetabular cup, unknown trilogy acetabular liner, all catalog#'s: ni all lot's#: ni.(b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined, as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will contribute to monitor for trends.

Event Description

It was reported in a journal article received that patient underwent a hip revision approximately 62 months post-implantation due to two dislocations, pseudotumor formation, and adverse local tissue reaction caused by taper corrosion.No additional patient consequences were reported.

• Brand Name: UNKNOWN 32MM HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6291054
• MDR Text Key: 66213254
• Report Number: 0001822565-2017-00458
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 81