MAUDE Adverse Event Report: ZIMMER, INC. STAGE ONE SELECT HIP SPACER HIP NECK LENGTH ADAPTER; PROSTHESIS, HIP

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Congestive Heart Failure (1783); Death (1802); Dyspnea (1816); Hypoxia (1918); Unspecified Infection (1930); Pneumonia (2011); Urinary Tract Infection (2120); Ulcer (2274)

Event Date 04/22/2015

Event Type  Death  

Manufacturer Narrative

(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: unk, unknown versys stem, unk; unk, unknown head, unk; unk, unknown shell, unk.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 05839; 0001822565 - 2017 - 05841; 0001822565 - 2017 - 05842.

Event Description

It was reported by patients legal counsel that the patient expired approximately two months post-implantation due to systemic septic infection, ulcers, uti, respiratory pneumonia, dyspnea, hypoxia and congested heart failure.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional/updated information.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (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 continue to monitor for trends.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.

Event Description

It was reported patient presented with several pressure ulcers at the right/left heels and coccyx sacral areas after admission to extended convalescent facility.Patient developed uti, respiratory pneumonia over 2 days evidenced by dyspnea and hypoxia with a worsening cardiac status showing congestive heart failure while residing in extended convalescent facility.Patient was subsequently readmitted to the hospital with sirs (systemic inflammatory response syndrome) secondary to pji complicated by chf, worsening respiratory and skin infections.One week after hospital admission, patient expired due to right hip infection leading to sepsis.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.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: STAGE ONE SELECT HIP SPACER HIP NECK LENGTH ADAPTER
• 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: 6802276
• MDR Text Key: 82976724
• Report Number: 0001822565-2017-05840
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080979
• 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,Followup,Followup,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• 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: 431187
• Device Lot Number: 109860
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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): Death