MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TPRLC 133 MP TYPE1 PPS HO 15.0; PROSTHESIS, HIP

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problems Cellulitis (1768); Unspecified Infection (1930)

Event Date 02/17/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4), cer bioloxd option hd 32mm, unknown.(b)(4), m/h radial solid/apx shl 50mm, unknown.Unknown e1 maxrom liner, unknown, unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-06093, 0001825034-2018-06094, 0001825034-2018-06095.Customer has indicated that the product will not be returned to zimmer biomet for investigation, [product location unknown].The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a patient was presented with cellulitis requiring treatment one month post implantation.No further information is available at this time.

Manufacturer Narrative

The following report is being submitted to relay additional information received concomitant medical products : 650-1057 cer bioloxd option hd 36mm, 650-1067 cer option type 1 tpr sleve +3, 13-104062 m/h radial solid/apx shl 62mm, unknown maxrom liner.The complaint cannot be confirmed since operative notes or x-rays were not provided from the event.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2018 -06093, 0001825034 -2018 -08931, 0001825034 -2018 -06094, 0001825034 -2018 -06095.

• Brand Name: TPRLC 133 MP TYPE1 PPS HO 15.0
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7753078
• MDR Text Key: 116119727
• Report Number: 0001825034-2018-06092
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PK110400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 51-107150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 109