MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRANSDERMAL COMPRESS ADAPTER; HIPS, PERSONALISED SOLUTION

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Bruise/Contusion (1754); Unspecified Infection (1930); No Information (3190)

Event Date 02/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded post surgery.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported patient underwent a revision procedure post implantation due to unknown reason.Attempts to obtain additional information have been made; however, no more is available at this time.

Event Description

It was reported patient underwent a revision procedure two (2) months post implantation as patient is a femoral amputee that is unable to wear a prosthetic because of the socket and liner issues, including skin infection, bacteria infections, blisters, bruises, and open wounds requiring wound care treatments.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Udi # (b)(4).Patient's initial pmi form was located.There are two adapters listed of different lengths.It is unknown which one was used.The 2nd taper adaptor which might have been used in th surgery is: pn: cp0001593 ln: 032830, mfg date: oct 30, 2018, exp date: oct 30, 2028, udi # (b)(4), 510k: exempt.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Concomitant medical products : cp0001590, trnsdrml cmprs spndl md 800lb, 790040, cp0001591, trnsdrml cmprs spndl collar md, 183740, cp0001593, trnsdrml cmprs adapter, 032830, cp0001594, trnsdrml cmprs adapter plug, 032790, cp0001595, trnsdrml adapter end cap, 784950, cp0001596, trnsdrml adapter sleeve, 780730, cp0001597, trnsdrml failsafe, 032730, cp0001598, trnsdrml collar impactor, 999120.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies 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.

Event Description

No further event information available at the time of this report.

• Brand Name: TRANSDERMAL COMPRESS ADAPTER
• Type of Device: HIPS, PERSONALISED SOLUTION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8325071
• MDR Text Key: 135690336
• Report Number: 0001825034-2019-00542
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CP0001592
• Device Lot Number: 738340
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention