MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM MOD HEAD COCR STD NECK; PROSTHESIS, HIP

Model Number N/A

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 05/25/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ep-108322 e-poly 32mm +3 hiwall lnr sz22 491650, 163669 32mm mod head cocr std neck 988510, 11-106048 r/b rloc lhole shl 48mm sz22 517710, 192411 echo por fmrl red nc 11x135mm 335960.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation shows the acetabular e1 bearing shows signs of potential fracture along the lip/edge of the bearing.The femoral head shows signs of possible abrasions.The acetabular shell was not returned.As stated in the sem analysis report there is a evidence for potential impingement on the intact bearing rim near the transition to the high-wall region of the rim.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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

It was reported that a patient underwent a hip revision procedure approximately five years post implantation due to breakage, dislocation, audible clicking sound, instability, and pain.The surgery was uneventful as was her rehab and postoperative period.During the surgery it was found that the liner was broken, the femoral head had deformed the shell to the point that the shell had to be removed and a new shell implanted.

• Brand Name: 32MM MOD HEAD COCR STD NECK
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7413148
• MDR Text Key: 104902036
• Report Number: 0001825034-2018-02500
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 163669
• Device Lot Number: 988510
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2012
• 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