MAUDE Adverse Event Report: ZIMMER, INC. MODULAR NECK E1 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Compatibility Problem (2960)

Patient Problems Host-Tissue Reaction (1297); Pain (1994); Reaction (2414)

Event Date 12/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).Concomitant products - liner neutral 36 mm i.D.Size ii/ pn 00875101036/ ln unknown, biolox⮠delta, ceramic femoral head, m, 㸠36/0, taper 12/14/ pn 00877503602/ ln unknown, shell with multi holes porous 52 mm/ pn 00875705202/ ln unknown, modular femoral stem press-fit plasma sprayed cementless size 7.5/ pn 00771300700/ ln unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2017-03678.

Event Description

It was reported that a patient underwent a left hip revision approximately four years post implantation due to patient allegations of pain and metallosis.There was also marked granulosis in the femoral component.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required as no were trends identified.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 continue to monitor for trends.

• Brand Name: MODULAR NECK E1 12/14 NECK TAPER
• 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: 6604753
• MDR Text Key: 76436885
• Report Number: 0001822565-2017-03679
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK071856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,health p
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/02/2017

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00784801201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: 09/30/2017
• Supplement Dates FDA Received: 10/03/2017
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention