MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. LINER 28 MM I.D. FOR USE WITH 50/51/52 MM O.D. SHELLS PROSTHESIS, HIP

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Hematoma (1884); Necrosis (1971); Joint Dislocation (2374)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products: zimmer cat# 01. 06010. 306 avenir stem lat cemented 6 lot# 3039253; zimmer cat# 00500105200 shell 52 mm o. D. Lot# 64892224. Report source: foreign country: (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 03693.

Event Description

It was reported that patient underwent a left hip arthroplasty. Subsequently, the patient was revised approximately 2. 5 weeks later due to dislocation. It is believed that the original femoral component was cemented too proud. The patient hip joint was believed to be too tight. It was revised to a smaller size stem and placed with more anteversion. Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4). Concomitant medical products: zimmer cat# 01. 06010. 306 avenir stem lat cemented 6 lot# 3039253; zimmer cat# 00500105200 shell 52 mm o. D. Lot# 64892224. Report source: foreign country: (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 03693.

Event Description

It was reported that patient underwent a left hip arthroplasty. Subsequently, the patient was revised approximately 2. 5 weeks later due to dislocation. It is believed that the original femoral component was cemented too proud. The patient hip joint was believed to be too tight. It was revised to a smaller size stem and placed with more anteversion. Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: LINER 28 MM I.D. FOR USE WITH 50/51/52 MM O.D. SHELLS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13110858
• MDR Text Key: 285184882
• Report Number: 0002648920-2021-00461
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 00500105028
• Device Lot Number: 64892224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• 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 Treatment Data

Date Received: 12/29/2021 Patient Sequence Number: 1